R&Q Resources

This is where you'll find our webinars, events, and more.

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Integrating CERs and Post-Market Surveillance

Data inputs, outputs, and everything in between.


That's a wrap! A recap of our Advanced EU MDR and ...

In March R&Q partnered with the Medical Alley Association in Minneapolis and..


R&Q adds former TÜV Rheinland North America Lead ...

Regulatory & Quality Solutions (R&Q) continues to grow aggressively – all while..


EU MDR for Combination Products

More companies will require notified body involvement.



EU MDR and the changing regulatory landscape.


Sufficient Clinical Evidence

A notified body perspective.


Top 10 EU MDR and CER Questions

Answers to the most popular questions we receive.


Economic Operators

Are they ready for EU MDR? Are you?


Understanding EU MDR and the Roadmap to Compliance

A guide to EU MDR for small companies.


CERs - Tips, Tricks, and Lessons Learned

Clinical background on the new requirements.


Proactive Post-Market Surveillance

The requirements and staff it takes.


EU MDR / CER Portfolio Planning

Know the essential EU MDR portfolio planning requirements.


Preparing your CER for MDR

Gathering clinical evidence.



Does your quality system meet the additional requirements?


Risk Management Updates

What to do with your process to meet the EU MDR/IVDR requirements.


Medical Alley Association Annual Dinner

April 24 — Minneapolis, MN


RAPS Convergence

September 21-24 — Philadelphia, PA


The MedTech Conference (AdvaMed)

September 23-25 — Boston, MA


🏅 Top 10 Questions: EU MDR and CER [Upcoming ...

Are you registered for our next free webinar yet? It's one you won't want to..


What does Brexit mean to your medical device ...

Hope for the best, but prepare for the worst.

EU MDR, CERs, California, DeviceTalks West

Our Advanced EU MDR and CER Workshop is coming to ...

  Note: Presenters/Panelists listed below subject to change. R&Q is bringing..

New webinars, major events... hello, fall!

First thing's first: our free webinars are back. Over the next three months..

R&Q, Careers

R&Q Q&A: Employee Spotlight and Career ...

This is our R&Q Q&A series. Every few months we ask R&Q employees how they make..

EU MDR, CERs, DeviceTalks Boston

Not your average EU MDR and CER workshop

Note: Presenters/Panelists listed below subject to change. DeviceTalks Boston..

Minnesota, DeviceTalks, DeviceTalks Minnesota

Taking it up a notch at DeviceTalks Minnesota

DeviceTalks Minnesota is right around the corner and we couldn't possibly be..

regulatory, EU MDR, CERs

🔑 Unlock the Secrets to CERs in our May Webinar

Unlock the secrets to complying with the increased requirements for CERs in..

EU MDR, Technical Documentation

💼 EU MDR – Proactive Post-Market Surveillance ...

It's time for our next free R&Q Intelligence Series webinar. The session – EU..

R&Q, Careers

R&Q Q&A: Employee Spotlight and Career ...

Welcome back to our R&Q Q&A series. Every few months we ask R&Q employees how..

EU MDR, Technical Documentation

📚 Technical Documentation for EU MDR [Upcoming ...

Our monthly R&Q Intelligence Series webinar is right around the corner and we..

Webinar Q&A: Preparing your CER for MDR

Note: R&Q's first Intelligence Series webinar of 2018 will be held on January..

Medical Devices, News, R&Q, EU MDR, R&Q Hires

Welcome, Jacob Foster: Regulatory and Quality ...

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory,..

CER, Clinical Evaluation Report, EU MDR, Clinical Evidence

Preparing your CER for MDR [Upcoming Webinar]

The upcoming EU MDR requires enhanced clinical evidence to support the device..

QMS, News, iso 13485, AAMI, Resources

ISO 13485:2016 Companion Handbook Now Available

ISO has published a companion handbook to ISO 13485:2016, Medical..

Webinar Q&A: EU MDR / CER Portfolio Planning

In September and as part of the R&Q Intelligence Series, we conducted the..

Webinar Q&A: Risk-Based Approach to ISO 13485:2016

Last month and as part of the R&Q Intelligence Series we conducted the..


EU MDR / CER Portfolio Planning: The Essential ...

What?  Please join us for September's free R&Q Intelligence Series webinar: EU..

MEDDEV 2.7/1 & CERs: Questions and Answers

Clinical evaluation requirements have been changing, with the latest impact..

Cybersecurity for Medical Devices: Questions and ...

As the number of network connected medical devices increases, opportunities for..


MDUFA IV: More Than Just User Fees - FDA ...

Pending the expected signature of President Trump, MDUFA IV will be implemented..

remediation, FDA, Case Studies, Clinical Evaluation Report, MEDEV 2.7/1

Clarifying the Clinical Evaluation Requirements: ...

About R&Q's Case Studies: We hope this Clinical Evaluation Report case study is..

Regulatory Affairs, EU MDR

EU MDR: Your Questions, Our Answers

On May 5, 2017 the EU MDR (Medical Device Regulation) was published in the EU..


Regulatory and Quality Solutions Names Julie Maes ...

Maes brings 25+ years of medical device regulatory, quality, and project..

cybersecurity, FDA

The Lowdown on Cybersecurity for Medical Devices

Every one of us has probably either been affected by or knows someone who has..

cybersecurity, Regulatory Intel, webinar, Quality Intel

[Free R&Q Webinar] Cybersecurity for Medical ...

What?  Please join us for a free R&Q Intelligence Series webinar: Cybersecurity..


RESOURCE: The MDR and IVDR Have Been Published! ...

Publication in the Official Journal of the European Journal on May 5, 2017..

webinar, CER, MEDDEV

MEDDEV 2.7/1 & CERs: Know the Changes and What to ...

Part of your month, [almost*] every month: R&Q Intelligence Series webinars are..


EU MDR and Clinical Evidence: What You Need to ...

THE SKINNY: The Council of the European Union adopted the proposed new European..

webinar, EU, Europe, European Union, EU MDR

EU MDR: Assessing the Impact and Next Steps ...

Part of your month, every month: R&Q Intelligence Series webinars are held on..


MDSAP: A Better Inspection Option for Device ...

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal..

webinar, audits, FDA, MDSAP

MDSAP: What is it? Is it for me? How will I get ...

Part of your month, every month: R&Q Intelligence Series webinars are held on..

FDA, regulatory, regulatory strategy, draft guidance

Review Controls Applied to Outgoing Data Streams ...

Medical device manufacturers need to carefully manage several important outward..

News, medical device news, Jake O'Donnell

NEWS: Bill Introduced to Improve FDA's Medical ...

Senator Johnny Isakson [R-GA] Note: This post is written by Jake O'Donnell,..

QMS, webinar, Risk, iso 13485

A Risk-Based Approach to Your QMS Implementation ...

Part of your month, every month: R&Q Intelligence Series webinars are held on..

remediation, FDA, 510(k) review, 510(k), Case Studies, Acquisitions

Acquisition Regulatory Assessments: A Case Study

About R&Q's Case Studies: We hope this Acquisition Regulatory Assessments case..

R&Q, Minnesota, Careers

R&Q Q&A: Minnesota Spotlight

Welcome to the third post in our R&Q Q&A series. Every few months we ask R&Q..

R&Q, Engineered By Women

Regulatory and Quality Solutions (R&Q) Certified ...

R&Q, provider of industry-leading regulatory and quality consulting and..

cancer, medtech, meddevice, wearables

A Cool New Way to Prevent Cancer Hair Loss — ...

♫ Baby, It's Cold Outside, especially in Texas, where a clinical trial showed a..

Pittsburgh, R&Q, Philadelphia

Headway in PA: Announcing Dedicated Operations ...

In 2016 R&Q expanded its activities and the amount of clients served in the..

Case Studies, process validation

Process Validation Case Study: Know What You ...

About R&Q case studies: We hope this process validation case study helps you..

QMS, iso 13485

Vital To-Do for 2017: Prepare for ISO 13485:2016

“Procrastination is the bad habit of putting of until the day after tomorrow..

iso 10993, iuvo BioScience

Slides and Webinar Recording: Chemical ...

Missed our webinar with iuvo BioScience - Chemical Characterization..

Ohio, BioOhio, Regulatory 101, startups

Next Up: FDA Regulatory 101 with Combination ...

This is the last FDA Regulatory 101 installment of the year for our partnership..

submissions, PMA, 510(k), advamed

Master 510(k), IDE, and PMA Submissions at ...

Within driving distance to D.C.? There's still time to enjoy a few days there..

massmedic, CAPA

CAPA on CAPA: Webinar Slides and Recording

Missed our CAPA on CAPA webinar with MassMEDIC? Now you can download the..

FDA, CDER, CDRH, Conferences

The REdI Fall 2016 Conference: Slides and ...

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum..

iuvo BioScience, ISO 10993-18

Free Webinar: Chemical Characterization ...

What? This joint webinar presented by Regulatory and Quality Solutions (R&Q)..

R&Q, Careers

R&Q Q&A: Northeast Employee Spotlight and Openings

Welcome to the second post in our R&Q Q&A series. Every few months we ask R&Q..

Medical Devices, quality systems, News, iso 13485, R&Q, Minnesota

Minnesota Momentum: R&Q Hires Member of ISO ...

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory...

warning letter, remediation, FDA, supplier quality, Case Studies

Revamping Supplier Quality: A Case Study

About R&Q's Case Studies: We hope this Supplier Quality Remediation case study..

remediation, FDA, Case Studies, CAPA, CAPA remediation

When CAPA Needs a Corrective Action: A CAPA ...

About R&Q's Case Studies: We hope this case study is valuable to you. Here are..

usability, Pittsburgh Technology Council, human factors

Medical Device Development: Avoiding Pitfalls in ...

This article was originally published in Summer of 2016's Made in PA issue, a..

Regulatory 101, PA Bio, Philadelphia, startups

Med Device and Med Tech Startups: Master ...

We all gotta start somewhere... and Pennsylvania Bio and Quorum have helped us..

QMS, audits, audit, Quality System

5 Reasons Not to Fear a Supplier Audit

The following post is written by R&Q Senior Engineer, Michelle Mahoney. One of..

News, FDA, 510(k) submission, regulatory news, compliance, 510(k)

What You Should Do About the Two New FDA Draft ...

It has been a long journey for the FDA to get the new draft guidances published..

Quality System, regulatory, massmedic

Free Webinar: CAPA on CAPA, Presented by ...

CAPA is often overlooked as an integral component of a quality system. More..

start ups, medical device, startups

R&Q's Christine Santagate Featured in Medical ...

Staying at the forefront of the medical device industry takes work - a lot of..

FDA, Ohio, BioOhio, Regulatory 101, Regulatory 201

July is a BIG month for R&Q in Columbus, OH

■ ■ ■ Are you an Ohio Bioscience Expo & Showcase attendee here to register for..

biosense, News, wearable tech, sensors, innovations, wearables

Wearables are Exploding (Not Literally!) and ...

Image via Verily Smart wearables are turning into a largely profitable..

iso 13485

10 Tips for Adopting the Updated ISO 13485:2016 ...

Missed our latest webinar on this year's ISO 13485 changes? Now you can..

usability, FDA, human factors, pma supplement, PMA, Case Studies, IEC 62366

FDA Approved: A Human Factors and Usability Case ...

About R&Q's Case Studies: We hope you enjoy our latest case study. View all of..

Medical Devices, UDI, MD&M East, md&m, Conferences

4 Things R&Q Learned At MD&M East

What an action-packed three days MD&M East was this year! Our team is..

Medical Devices, OSA, Clinical Studies, medicaldevice, Sleep apnea

This New Med Device Will Help You Sleep Better

Everyone appreciates a good night's sleep. A big obstacle to that is the fact..

RAPS, industry guidance, regulatory news, regulatory, Industry Advice

Industry Advice: Earn RAC Points and Enhance Your ...

You've already read a few benefits in the title but let's reiterate: Earn RAC..

R&Q, Careers

R&Q Q&A: Boston Employee Spotlight

Welcome to the first post in our R&Q Q&A series. Every two months we'll ask R&Q..

3d printing, medical device, meddevice

The Med Device Industry (and the FDA) Embrace 3D ...

Just this week the world's first 3D-printed office opened in Dubai. It took all..

Engineered By Women, entrepreneurship

R&Q: Engineered by Women

Did you know that women are half as likely as men to start businesses? That's a..

UDI, massmedic

A Whole New World of UDI: Slides and Recording

If you have any UDI needs or questions, do not miss this post.

medtech, md&m, Conferences

MD&M East Expo and Conference: June 14-16

Be a part of the largest and most influencial medical manufacturing event on..

FDA, PA Bio, Philadelphia, Pennsylvania

Presentation and Networking at PA Bio: Practical ...

NOTE: This event has been cancelled and is being rescheduled. Organizer..

iso 13485

The New ISO 13485 Standards are Here! Sign Up for ...

The world's most well known standards for medical device quality management..

human factors, advamed, design controls

AdvaMed Workshop: Integrating Human Factors into ...

Attention any and all regulatory affairs specialists, engineering managers,..

FDA, compliance, UDI, massmedic

MassMEDIC Webinar: A Whole New World of UDI - May ...

If you missed R&Q's Paul Robinson discuss UDI during R&Q's afternoon workshop..

PA Bio

PA Bio Connect@ - May 9 in Philadelphia

Great news, Philly! EisnerAmper will be hosting the Pennsylvania Bio: Connect@..

FDA, compliance, advamed

AdvaMed Webinar: Avoiding and Managing FDA ...

Did you miss former FDAer Jake O'Donnell speak about avoiding and managing FDA..

inspection, fda inspection, FDA, white paper, compliance

NEW White Paper - Practical Considerations for ...

There’s a formula for effectively managing an adverse FDA inspection and the..

Minnesota, Medical Alley

Minnesota, Here We Come: See You at the 2016 ...

R&Q will be a Supporting Sponsor at the Medical Alley Association's 2016 Annual..

IVD, compliance, UDI, Boston, IVDR, BIOMEDevice, Workshops

R&Q's Can't-Miss Education Event of the Year: An ...

Those in the northeast, get ready! Not only will R&Q be exhibiting at this..

Clinical Studies, Case Studies, Clinical Evaluation Report

When Benefit Outweighs Risk: Creating a ...

About R&Q's Case Studies: We hope you enjoy our third case study. View all of..

regulatory strategy, Case Studies

5 Heads are Better Than 1: De-Risking Your ...

About R&Q's Case Studies: We hope you find value in our second case study. View..

remediation, Case Studies, Design History File Remediation

Introducing Our First In A Series of New R&Q Case ...

About R&Q's Case Studies: Our goal in producing case studies is to succinctly..

FDA, Ohio, BioOhio, Regulatory 101

Announcing the 2016 FDA Regulatory 101 Series

Medical device professionals in Ohio, are you ready? Last year R&Q teamed with..

510(k) submission, 510(k) review, 510(k), advamed, Workshops, Education

Hear R&Q and Other Industry Experts Discuss ...

Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other..

Medical Devices, CT Scanner, Creativity, New York

Revisiting a Classic: The Pirate-Themed CT Scanner

Behold medical device ingenuity at its finest. In 2013 the NewYork-Presbyterian..

M2D2, UMass, Boston

R&Q Is Sponsoring The M2D2 $100K Challenge and A ...

The University of Massachusetts Medical Device Development Center (M2D2) has..

Combination Products, Boston

Presentation and Networking: Is A Medical Device ...

Organizer Us! Regulatory and Quality Solutions (R&Q) What? A presentation and..

Medical Devices, News, FDA, R&Q

Announcing R&Q's Newest Senior FDA Compliance ...

R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will..

Medical Devices, R&Q, Video

We Made a Video About R&Q! Here's Why.

One of R&Q's priorities in 2015 was to find new, distinctive ways to tell our..


Welcome To R&Q's New Website!

Welcome to R&Q's updated website! To state it plainly, we've revamped our..

Notified Body Expectations: Today, Tomorrow and ...

  R&Q and Nerac invite you to attend a free medical device event and panel..

Ten Tips for A Successful Use of Total Product ...

The FDA, as part of the transparency initiative, has developed a Total Product..

Ten Tips for Successful Integration of Risk ...

Even though Risk Management and Usability Engineering are clearly two separate..

510(k) Submissions-Ten Tips for a Successful ...

The process of submitting a 510(k), demonstrating that your device is..

Successful Regulatory Strategy-Ten Tips

Having a documented regulatory strategy developed early during a new product’s..

CAPA - Best Practice Sharing

Healthy CAPAs = Competitive Advantage

Implementing a Successful Recall Process - Ten ...

In the medical device arena, recalls are a fact of life and competitors love to..

Warning Letters - Ten Tips

Each year, the FDA issues hundreds of warning letters to medical device..

Q-Sub, FDA, Guidance Document, Pre-Sub, PMA, 510(k), Pre-Submission

Pre-Submission Program – Final Guidance

On February 18, the FDA issued the final guidance document for the..

Affordable Breakthrough Innovations

Innovative ideas for medical devices are often costly for manufacturers to make..

guidance documents, 23andMe, FDA, Custom Device Exemptions

Guidance Documents for 2014

In an effort to help get safe and effective medical devices to market more..

FDA, medical device, PMA

Pediatric Subpopulations – Final Rule

On Friday, January 10, 2014 the FDA issued a final rule, which amends the..

FDA, 510(k) review, 510(k), CDRH

510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is..

3D Printing in Medicine

As if 3D printers for rapid prototyping weren’t cool enough, researchers at the..

Regulatory News - Report on FDA Device Review ...

As part of FDA’s Performance Goals and Procedures adopted under MDUFA III (The..

Transhumanism, Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Conclusion

Trans∙hu∙man∙ism /tranz’hyoomənizm// Noun The belief or theory that the human..

Medical Devices, military

Devices for the Military

This past weekend I travelled to the Chicago-land area to attend my brother’s..

Veterinary Medical Devices - FDA Regulations

I recently worked on a project that involved writing a regulatory strategy for..

Getting to Know You

You probably think you know yourself pretty well, right? Of course. You’re a..

Devices remain unclassified

I read a really interesting article this week written by Josh Rising called..

culture of quality, quality

A Culture of Quality

As quality professionals, we are always looking for ways to improve the quality..

Not-So-Blind Ambition

Can you imagine what a GPS for blind people would be like? We may not be there..

RAPS 2013 Series: MDSAP

Of all of the seminars I attended at the RAPS 2013 Conference in Boston, the..

Quality Control for Blood Transfusions

Over the years, major advances in blood transfusion safety measures have..

Diabetes, Artificial Pancreas, FDA, Artificial Organ, PMA

First Artificial Pancreas receives FDA Approval

Upon my nightly adventures of surfing the World Wide Web I came across this..

medical device manufacturers, device manufacturers, Affordable Care Act, medical device news, Medical Device Tax

On the Edge of Our Seats

As the government shutdown dragged onward, nobody was watching the outcomes..

Medical Devices, Artificial, Larynx, cancer, Clinical Studies

Deep Breaths

The standard treatment for patients with cancer of the larynx is to have a..

Government Shutdown - Impact on Medical Devices

On October 1st, 2013, the Government of the United States began shutting down..

Bionic, Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Part I - ...

Advancements in biotechnology have made things of science fiction into reality...


In the world in we live, where communication is becoming further removed from..

FDA, medical device, Risk-Benefit, Patient Preference

FDA gives Voice to the People

The Center for Devices and Radiological Health (CDRH) at the Food and Drug..

RAPS 2013: Education Series

Last week, R&Q attended the RAPS 2013 Conference held in Boston, MA. We were..

Medical Devices, artificial knee, running, biomechanics

Pounding the Pavement

Earlier this year I joined a running club, Steel City Road Runners (come run..

R&Q at RAPS 2013!

Good morning!

FDA Releases Mobile Medical Applications Guidance ...

This week must be the week of the FDA publications. In the same week the UDI..

Retraining the Brain – A New Approach to ...

Schizophrenia is a debilitating neurocognitive disease that affects about 2.4..

UDI Documents Released by FDA

The rule and guidance document for Unique Device Identifiers ("UDI") on medical..

EU marketing approval system

The European marketing approval system for medical devices is less stringent..

india, labeling, medical device industry, medical device, compliance, regulatory, registration

India Medical Device Labeling

This week I will provide some information about labeling in India. CDSCO..

Regulatory and Quality Solutions, RQS, regulatory, Regulatory Pathways

Same Road (Regulatory Pathway), Different Car ...

As you might expect, here at RQS the responsibilities and duties of providing..

Transhumanism, Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Intro

What do Jean Grey and Professor Xavier of X-Men, Vulcan “mind-melds” from Star..

International Labeling Requirements

It used to be much easier to have an international device on the market that..

Brain disease, iso 14971, risk management, Harm, Sequence of Events, Hazardous Situation, sterilization, Hazard

Foreseeing the Risks

On the news this morning, I heard a story that got me thinking about risk..

510(k)-Exempt Devices

In the FDA-regulated medical device world, there are 3 classifications for..

Personalized Orthopedics

As part of a growing trend toward personalized healthcare, the medical device..

FDA guidance document on RF Wireless Technology ...

With the growing use of incorporating wireless technology into medical devices,..

Improved machines based on human biology

Today, when I was thinking of a blog topic, I had a moment of clarity. I..

Genome, Medical Advancement, HeLa, Henrietta Lacks

Recognition for Contributions in Medical ...

In my Bioethics course during my undergraduate years, we had discussed the..

Medical Devices, Reliability, Use Case, HALT, quality

Reliability – From Bike Racks to Medical Devices

Every once in a while, when I’m not running, I like to take my bike down to the..

massage therapy, medical industry, massage, Insurance, therapy

Vacation Revelation

I am in TopSail North Carolina this week enjoying the ocean, sun and family!..

Fear Factor: Audits

Why is it that when you drop the A-bomb (audit) people just seem to..

RQS Ohio Social Event - August 14, 2013

Please join RQS for a happy hour networking event! Drinks and appetizers will..

guidance, CDER

Guidance document clean-up! - CDER

I read an interesting article on the RAPS website this morning about a new..

Draft Guidance on Medical Device Reporting for ...

Earlier last month, FDA released a new draft guidance that addresses many..

nutrition, supplements

Super Supplements or Scary Supplements: Consumers ...

While doing my usual read-through of the headlines on USA Today, I recently..

standards, iso 14971, risk management, Standards Compliance

“It’s like getting your high school diploma…”

Recently, I had the opportunity to attend a Risk Management Conference hosted..

Just Say No

So you think you’re a bargain shopper, huh? Did you secretly get a rush when..

FDA Medical Device Reporting Update

One of the ways that I try to stay in touch with the world of medical device..

Ombudsman, CDRH

How the FDA handles complaints

Complaints from end users to medical device manufacturers are unfortunately a..

fundamentals of engineering

Documentation 101: Life as an Engineer

As a recent college graduate working in the medical device industry, I quickly..

Croatia Joins the EU

As of June 30th, Croatia has now been formally added to the list of EU governed..

A Vaccine for Colon Cancer

As a University of Pittsburgh graduate, I was excited to read in the spring..

The Importance of Production Equivalence

In today's world of always looking for ways to get something done faster there..

cybersecurity, premarket submissions, risk analysis approach, patient data, security breach, mobile apps, medical device design


My recent work has involved providing regulatory assistance to software medical..

My Day at FDA

For today's show-and-tell, I'm bringing a picture of me at FDA:

FDA Inspections Database

The Food and Drug Administration (FDA) recently released its new data set for..

congenital heart defects, RQS, heart to heart, medical technology, quality solutions, birth defect, north park

Congenital Heart Walk

This weekend my family and I are going to go to the Congenital Heart Walk at..

software system, regulatory focus, www.fda.gov, FDA, FDA website, maude database, software, regulatory, Graematter, Regulatory Intelligence

Regulatory Intelligence

How much time to you spend searching FDA’s website? Looking for predicates,..

Eye Spy

Every time I visit my optometrist I see advertisements for colored contact..

Consumer Medical Device Adverse Event Reporting

Recently I went trolling through the FDA website and stumbled upon an article..


Integration Phase - AGILE vs. Regulatory

An AGILE software development process allows for adaptive development through..

Race for the Place and RQS Cares

After reading Steve’s blog, "Why RQS Cares- The Race for the Place" and..

Mobile Medical Applications - More Apples, More ...

Could it get much worse for mobile medical applications and their developers..

Medical Devices, medical device industry, FDA, K97-1, Guidance Document, regulatory, 510(k)

FDA 510(k) Memorandum #K97-1 “Deciding When to ...

The FDA is looking for industry input for the revision of FDA 510(k) Memorandum..

Medical Device Report, Complaint Handling, MedWatch, Complaints, FDA, medical device, MDR, Adverse Event, Post Market Vigilance

Complaint Handling Solutions

In my last post “Who’s watching your MedWatching”, I commented on some of the..

Medical Cybercrime

I saw an episode of Elementary a couple weeks ago in which a hired assassin..

internal auditor, quality system procedures, quality procedures, compliance, internal audits

Internal Audits, the After-Thought of a Quality ...

Why is it that Internal Audits are forgotten, or even worse feared? Why is it..

AGILE, medical device, 62304, software development

Using AGILE in Medical Device Software Development

In school I was always taught that the medical device development process..

MedCon 2013

At the beginning of this month, MedCon 2013 was hosted in Cincinnati, OH by..

Localization Issues

Last month Serbia changed its localization so that The Instructions for Use and..

Training, a Test of Endurance

I was blessed enough this weekend to run the Pittsburgh Half-Marathon with my..

cancer, gathering place, diagnosis treatment, race for the place, cancer survivor, brain cancers

Why RQS Cares - The Race for the Place

  Today we feature a post from Steve Keverline on why RQS Cares has chosen to..

When Will Academia Catch-up to the Needs of the ...

This past weekend I had a really great discussion with some neighborhood..

Everyday Usability – Alarm Clock Edition

I’ve always had a rocky relationship with my alarm clock, specifically the..

RQS, runners, registrations, gathering place, walkers, race for the place, cancer survivor

RQS Cares - Race for the Place

RQS is happy to announce that RQS Cares is organizing a group for the Race for..

investors, patent, patent application, first to file, medical device, patent office, law, Innovation, first to invent, us patent law, patent system

Patent Law Changes

For over 200 years, the US has operated under a “first to invent” rule. This..

ergonomics society, alarms, usability, false positives, alarm systems, medical device, iec 60601, human factors

An Alarming Trend

If you’ve ever spent any appreciable amount of time in a hospital or other..

FDA's Guidance of User Fees and Refunds for ...

This morning I was welcomed by receiving an email from the FDA CDRH News..

Japan PMDA, EU, audits, TGA, GHTF, FDA, health canada, quality improvements, iso 13485

FDA’s Guidance Document on Voluntary Submission ...

I came across an FDA guidance document – not entirely recent; however, I found..

audit, medical device

Audit Training

I recently had the opportunity to receive some training in auditing of medical..

trade, MDD, Medical Devices, trade deadline, trade-off, nhl, iso 14971, risk management, 14971, FDA, business risk, cmdr

Medical Device Development: Trades

As a somewhat rabid hockey fan there are a few days during the year that are..

3d printing, FDA, medical device, 510(k), additive manufacturing, oxford performance materials

Medical “Wow”: 3D Printed Skull

Last week I saw several articles published about a new device that is going to..

Medical Devices, medical device development, March Madness, medical device industry, Innovation

March Madness

The season is upon us. Unfortunately, the season is not spring…winter still..

quality agreement, 21 cfr, supplier selection, medical device industry, FDA, supplier management, supplier quality

Getting Control of Supplier Controls

It seems that for one reason or another supplier controls are a requirement..

pittsburgh tech, RQS, teq, quality solutions

RQS appears in TEQ Magazine

In the March 2013 edition of the Pittsburgh Tech Council's TEQ Magazine,..

language development, Medical Devices, cochlear implant, medical technology, cochlear implants, FDA, bionic eye, implant device

Make Sense

My son has a friend that was born deaf. When he was a small child, he had..

standards, european commission, IEEE, MDD, Medical Devices, BSI, medical device field, medical device manufacturer, country code, FDA, ASTM, RTCA

Keeping Up With Regulations

In the medical device field the name of the game is Compliance. The reason for..

best practices, Quality System, autonomy, Guidance Document, Innovation, regulatory, improvements, quality

Autonomy with Boundaries

I have a teenager that just passed his Driver’s Test. As he pulls out of our..

tax payer dollars, medical device manufacturers, fda budget, new medical devices, FDA, advamed, improved products

FDA Budget Cuts This Week

This week, the FDA faces between 5.1 to 5.3% of their budget being cut this..

Da Vinci, medical device industry, technology, medical device, technology advancements, surgery system, Robot-assisted, Intuitive

Technology Overkill?

Over the past few years, there have been some really great technologies that..

risk analyses, probability, residual risk, risk analysis, severity

Go Ahead, Take a Chance

Throughout our daily lives, we assess risk. At the grocery store, driving to..

medcity, technology hub, research triangle park, innovation center, life science industry

Cleveland Rocks… its way to the top five growing ...

After many years of adamantly claiming not to have a “hometown,” hating the..

NBC, Universal Sports, curling

Curling Nationals!

Something very exciting is happening this week in Green Bay, Wisconsin. The..

QMS, MDD, EU, Canada, Medical Devices, FDA, health canada, 21 cfr 820, Preventive Action, iso 13485

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word..

standards, MDD, iso 14971, medical device, Medical Device Directive, ISO, iso 13485

Making Sense of Standards

You may have heard that last year there were two new releases of EN standards:..

medical device industry, taxes, FDA, medical device, public health, govenment, regulatory, 510(k), CDRH


The FDA received funding to increase its workforce at the CDRH for 2012 and..

Medical Devices, visual signal, risk level, alarm systems, safety feature, compliance

Auto Compliance

Coming to your commercial break at the 2014 Super Bowl at Met-Life Stadium -..

internal auditor, auditee, external auditor, compliance, observation, Preventive Action, internal audits, corrective action

Thoughts About Auditing

'Tis the season for auditing. The beginning of this year, just like years in..

gmp, final rule, FDA, medical device, Pharma, Biologics, Combination Products

Final Rule - Combination Products

Last week, the FDA issued a final rule(1-2) on combination products(3) and the..

medical device review, FDA, Guidance Document, PMA

Acceptance and Filing Reviews for Premarket ...

In addition to the Refuse to Accept Policy for 510(k)s Guidance document I..

Value Chain, Medical Devices, x-ray, healthcare, Insurance, customer

Who is your customer?

My mom works as an x-ray technician at a small orthopedic office in..

requirements, argentina, brazil, international, China, labeling, registrations, venezuela, mexico

Small Label, Big Impact

There have been a bunch of countries recently that have changed their..

quality product, Quality System, customer feedback, supplier evaluations

Some Things Never Change....

There are some things in life that never change. So, if they never change,..

Medical Devices, Regulatory Affairs, medical device manufacturers, maude database

Medical Devices and Fantasy Football, More in ...

I constantly find myself trying to draw parallels between my work life and..

listing, MDD, EU, Medical Devices, us, gmp, mdufa III, FDA, FDASIA, enforcement actions, registration

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:

adverse events, hip replacement, surgery, safety communication, FDA, medical device, implantables

Hitting Home

One of the more personal aspects of why I work in regulatory and quality is..

quality management, FDA, medical device, 21 cfr 820, Joseph Juran, quality, iso 13485

Architect of Quality - Part 1

Have you ever wondered where quality management systems came from, or why these..

proposed rule, Unique Device Identification System, Unique Device Identification, UDI

Identification... Unique Device Identification.

The other night, while I was drinking a refreshing beverage (neither shaken,..

RTA, submission, FDA, medical device, 510(k) submission, 510(k) review, Guidance Document, Refuse to Accept, 510(k)

New "Refuse to Accept" Guidance Document for ...

There has been much controversy about the new RTA FDA Guidance document titled..

fashion, consulting

Be Smart: Look Smart

I wanted to write about an interesting event that a group of us at RQS had this..

The Promise

Training is an integral part of what we do at RQS, whether it’s one on one or..

Quality Lessons of a New Parent

2012 brought many new challenges to my life. Some dealt with changes in my..

Mobile Medical Applications - Only a Bandage?

Often enough, I'll hear or say, "It's just a bandage" (to avoid the popular..

A Fresh Start

Every New Year, many of us take stock of our lives and make resolutions to live..

Holiday Anecdotes

Quick thoughts from my holiday time with my family:

Regulatory Intel - Alerts, Updates, Newsletters

Quite appropriate for the season, I found a little "gift" in my documents..

Medical Devices, Holidays, Christmas, labeling, Intended Use, Stents, Risk, Hazards

Unwanted Gifts

Have you ever received a gift that you didn’t really want? Was it an ugly..

Mobile Medical Applications - Progress?

I'll admit, I'm a sucker for the "Best of " everything for whatever reason. Why..

Heart to Heart

Seven years ago today, I waited by the phone. Waiting for the news that my..

MDD, EU, FDA, health canada, medical device, cleveland

Mistake, I Think Not!

As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I..

biodegradable circuits, ingesting medical device, medical device, biodegradable, circuits

Biodegradable Circuits

When I first heard the words “biodegradable” and “electronic devices” together,..

Medical Devices, NASA

Astronaut Icecream and Medical Devices

In recent years, my father has picked up a new hobby of star-gazing. What..

MDD, EU, label, Regulatory Affairs, RQS, labeling, ifu, FDA, health canada, medical device, user guide, instructions for use, manual

Labels impact the device

During this holiday season, when presents are being packaged and shipped at..

FDA, medical device, regulatory

Call me a (Juris) Doctor!?

I was going to write about China Labeling this week, but I didn't feel like it!

Biocompatibility, mobile medical applications, Precedence, FDA, Substantial Equivalence, regulatory, 510(k), quality

Setting Precedence

I sat down tonight, as I do every night that I write a blog post, and I started..

Biocompatibility, MDD, EU, Medical Devices, 10993-1, FDA, health canada, medical device, Medical Device Directive, 10993

Biocompatibility - Simple, Right?

I’ve been working in regulatory for a company in which biocompatibility of..

MDD, EU, end user, FDA, health canada, medical device, customer

In Your Face

My teenager works at a local eatery – I thoroughly believe the saying, “A good..

What is the Medical Device Excise ?

Let me start my blog off by stating that I personally love tracking politics...

New Heights in Prosthetics

About a week ago I read an article in Mechanical Engineering magazine that I..

Medical Devices, News, FDA, marketing, off-label

United States v. Caronia

Yesterday, the United States Court of Appeals for the Second Circuit (based in..

WIB, healthcare, health, Eliza Corporation, Women in Bio, Alexandra Drane

Women in Bio Success!

This past Thursday (11/29) several RQS employees were fortunate enough to..

MDUFMA, Small Business, User Fee, Pediatric, PMA, 510(k), Discount

Deals and Steals

Thanksgiving night I was standing outside in the cold in a line that wrapped..

quality systems, production quality, design quality, China, FDA, medical device, regulatory, quality

International Spotlight - China

When people ask my opinion of the most difficult country to register medical..

post market surveillance

No Time for Common Sense

Last week, I had a computer issue...not a big issue, more like an annoyance...

Can't we just all get along?

Why is it that anytime a project is underway that it seems as if quality is an..

Balancing Act

Early in product development, it’s easy to be overly optimistic about designing..

Doctor Mario to Surgery, please… Doctor Mario to ...

When you think of video gamers or computer gamers, what typically comes to..

Truth Behind Facts

My focus lately has wildly been on healthy eating, various diets and finding..

Pittsburgh, networking, Women in Bio

Women in Bio - November 29th Kick-off Event

On November 29th the Women in Bio (WIB) Pittsburgh chapter will be having its..

Mobile Medical Applications - Call Security!

In an odd turn of coincidence, I have been involved in more discussions..

Regulatory Intel - Government Databases

One challenge that many regulatory professionals face is finding applicable and..

Medical Devices, acronyms, Drugs, NDA, 510(k), Combination Products, Pharmaceuticals

Exploding Bombs?

I have to admit, school doesn't teach you everything. During my first week at..

Steven Casey, Medical Devices, usability, technology, human error, human factors, phasers

Set Phasers on Stun

Several years ago a good friend who knows my interest in human factors and..

medical device, Innovation, Cleveland Clinic

Rethinking Innovation

One of my favorite topics about the medical device industry and technology in..

When the Lights Go Down in the City

Just the other day, I left work with high ambitions of going to the gym...

inspection, warning letter, FDA, 483, medical device, EIR

Stay out of Frying Pans and Fires!

Quick note today as a training seminar came through my inbox.

Lessons of a High School Speech Geek

When I was in high school, I was a speech geek. Every Saturday during the..

FDA, medical device, comprehensive regulatory assistance, Linkedin

Searching for Medical Device Info

As a recently new professional in the medical device industry, I try to find..

Medical Devices, Halloween, Courses, Training, Learning, FDA

Training and a couple jokes

Trick-or-treating in my neighborhood was moved to Saturday this year because of..

Left Wing, Right Wing, or Somewhere in Between

In the spirit of November’s highly anticipated Presidential Election, an..

Need a Hand?

Have you ever felt like you were trying to do too many things at once and could..

literature review, medical device

Conducting a Literature Review

One issue that came up last week with a client was how to conduct a literature..

mHealth, idiom, mobile medical applications, mma, medicaldevices, medical device, Apps, titanic, medicaldevice

Mobile Medical Applications: Titanic Chairs

I've often believed that the number of idioms and quirky phrases describing a..

Clinical Studies, Stents, Guidance Document, Women in Bio, Breast Cancer

October brings awareness to women’s health issues

October is a very important month for women: It’s National Breast Cancer..

User Research Methods

So you’re designing a new medical device and you want to gain a better..

Great Lakes Venture Fair

Last week, Regulatory and Quality Solutions, attended the first Great Lakes..

medical device, compliance, standard

Keeping up with Standards

With recent clients I have been dealing more and more with new standards coming..

Medical Devices, Stents, Innovation, PMA, de novo, Disruptive Technology

Blockbuster is no more - A discussion on ...

Every time I go home to visit my parents, one thing that comes up more often..

The Change Agents

…cue Mission Impossible Theme Song…

medical device

Medical Devices in Different Markets

I recently took a two week vacation to South Africa traveling to Cape Town,..

Excise Tax, medical device, Tax, Affordable Care Act, Medical Device Tax

Medical Device Tax: Funding Healthcare for ...

In the second of the two part series, we'll review support of the 2.3% tax of..

MDD, Medical Devices, Europe, CE Mark, Pittsburgh Technology Council

Devices Regulations in Europe

On Tuesday, I attended a Pittsburgh Technology Council event downtown titled..

Kickstart, Veteran's Affairs, medical device, orthosis, Cleveland Clinic, Cadence Biomedical

Now that’s some real horse power

Our neighbors located up the street from our Cleveland, OH location, at the..

Moderating Usability Testing

Since I’m in the middle of several usability testing projects right now, I..

Excise Tax, medical device, Tax, Affordable Care Act, Medical Device Tax

Medical Device Tax: Windfall or Pitfall?

Thanks to Sherri's earlier post, we've begun to explore the landscape of the..

medical device review, FDA, medical device, Emergo Group, CDRH

Creating Consistency

One major variable med tech companies are faced with today is the unknown of..

Mission, Medical Devices, Substantial Equivalence, Innovation, Intellectual Property, 510(k)

Navigating Substantial Equivalence

Part of the mission of the CDRH is to ensure medical devices are safe and..

proposals, EU, FDA, CE Marking, European Union, new legislation, FDASIA, September

More changes heading our way?

After a recent statement by the EU health commissioner, it appears that..

RQS on YOUR Airwaves

Another thanks must go out to the Pittsburgh Technology Council for hosting RQS..

Real Service

“I need a 25 foot garden hose, do you have one?”

Medical Devices, Patents, Intellectual Property


Eureka! A light bulb goes off, and suddenly you’ve invented a great new medical..

Medical Device Design for Cross-Cultural Use

As if it isn’t challenging enough to design a medical device that can be used..

Pittsburgh Social Exchange, Pittsburgh Technology Council, networking, SMaSh

Networking Success!

The Networking with Technology event hosted by the Pittsburgh Technology..

Unexpected Benefits

Medical Device Companies are required to comply with various regulations, based..

Setting Realistic Expectations of Medical Device ...

During recent usability testing of an updated medical device, I was reminded..

Networking with Technology

Several RQS employees will be attending the Networking with Technology event..

Standing Out vs. Fitting In

Innovators are constantly being pulled in different directions on whether they..

Cleveland, We Have a Problem

Since this is my first contribution, let me give you the intro - my name is..

telemetry, MBAN, FDA, wireless medical device, FCC

Healthcare going mobile

Hospital patients (and hospital staff) no longer have to grow weary of the..

Creating Growth and Improving Performance

I recently read an article that focused on describing what it takes for a..

RQS on the Airwaves!

Thanks to the Pittsburgh Technology Council and their TechVibe Radio program,..

Death and Taxes

We’ve heard it before: “There are two things certain in life: death and taxes.”

Success Rates for Usability Objectives

Continuing our discussion about usability objectives from last Wednesday, a..

nanomaterials, medical device industry, medical device, nanotechnology, FDASIA, med-tech industry

Nano-what? Nanotechnology.

Over the past 50 years, the advancement of technology has been beyond..

Becoming a Successful Consultant

Since I am a recent graduate and new to the work force, I wanted to discuss..

PTC Breakfast Briefing on EU Market

Pittsburgh Technology Council (PTC) is hosting a Breakfast Briefing on October..

FDA Releases Mission, Vision, and Shared Values

The core of strong organizations can be found in its mission and its vision...

What's taking so long?

How long does it take to get device clearance through the 510(k) pathway? Does..

FDA: Jekyll or Hyde?

Black and white. Yes and no. On and off. Absolutes. Extremes. Exactly what our..

Defining Usability Objectives

If you ever plan usability testing activities for a medical device, you may..

Walking like an Egyptian

Recently, the little brother of my close childhood friend and his family..

RQS Honored With Tech 50 Nomination

Yearly, the Pittsburgh Technology Council issues awards, the Tech 50 awards,..

An Idea Around Innovation

Hello and welcome! This is the kickoff blog to RQS’s new daily blogging social..

RQS Rises to Top of Pittsburgh 100

As announced Thursday at a ceremony and reception hosted by Pittsburgh Business..

RQS in the News - Cleveland Office Opening

Regulatory and Quality Solutions is in the news again, this time featured in..

FDA ISO 13485:2003 Pilot Program

Effective June 5, 2012, FDA will begin a voluntary pilot program to accept..

Upcoming Webinar - Common Mistakes for Medical ...

BSI is hosting a webinar on April 24th, 2012 at 11:00 AM on the 7 common..

Everyday Usability 14

Well folks, our Everyday Usability photo series has come to an end with this..

RQS in Top 25 of Best Places to Work in Western ...

As announced last Wednesday, October 19th, 2011, Regulatory and Quality..

Everyday Usability 13

For our penultimate edition of Everyday Usability, we take a look into what the..

Everyday Usability 12

Good morning blog folks! I greet you this morning with a familiar topic from..

"Cheap" Microscope Anyone?

Biotech's slow coup of the mobile industry never ceases to amaze me. In this..

Incentive-Based Regulation: Is it possible?

As some who know me would tell you, my mind happens to wander at times about a..

Everyday Usability 11

A great example of usability engineering is right in front of us every day..

Improving Device Human Factors Through Focus ...

When designing medical devices it is important to identify use-related hazards..

Acne Apps Dried Up by FTC

In light of the recent drafts of the FDA's regulation and guidance for..

Everyday Usability - 10

Here in our tenth edition of Everyday Usability, we'll discuss the usability of..

Disney's Root Cause Analysis?

My son was watching Disney's Beauty and the Beast in the car this weekend and I..

EN 62304 Certification?

Last week, I guided a client and their software developer through a notified..

Everyday Usability 9

Yankees - Redsox. Democrats - Republicans. French - British. Google - Apple...

RQS Nominated for 2011 Best Places to Work

Regulatory and Quality Solutions, LLC was recently announced as a nominee as..

FDA Issues Draft Guidance for Clinical ...

On 8/29/2011, the FDA issued a Draft Guidance recommending changes to..

Everyday Usability 8

I was discussing quality system documentation with a colleague yesterday when..

FDA Regulation Goes Mobile

Mobile medical applications are revolutionizing the way that healthcare is..

Everyday Usability 7

There must be something about the simplicity and innocence of children that is..

PBT Article on RFID Tagging Quotes VP Casavant

In the July 29th to August 4th edition of the Pittsburgh Business Times, Kris..

Everyday Usability 6

Have you ever felt like an idiot for walking straight into a doo

IOM Issues Report on the FDA's 510(k) Process

The Institute of Medicine (IOM) has released their latest report regarding..

Everyday Usability 5

Ever attempt to open a carton of milk, but end up splitting the lip of the..