R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.


What does Brexit mean to your medical device company?

Our Advanced EU MDR and CER Workshop is coming to California in December at DeviceTalks West

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

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

Not your average EU MDR and CER workshop

Taking it up a notch at DeviceTalks Minnesota

🔑 Unlock the Secrets to CERs in our May Webinar

💼 EU MDR – Proactive Post-Market Surveillance [Upcoming Webinar]

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

📚 Technical Documentation for EU MDR [Upcoming Webinar]

Webinar Q&A: Preparing your CER for MDR

Welcome, Jacob Foster: Regulatory and Quality Solutions' New Senior Principal Engineer

Preparing your CER for MDR [Upcoming Webinar]

ISO 13485:2016 Companion Handbook Now Available

Webinar Q&A: EU MDR / CER Portfolio Planning

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

EU MDR / CER Portfolio Planning: The Essential Requirements [Free Webinar]

MEDDEV 2.7/1 & CERs: Questions and Answers

Cybersecurity for Medical Devices: Questions and Answers

MDUFA IV: More Than Just User Fees - FDA Reauthorization Act (FDARA) Passes Senate

Clarifying the Clinical Evaluation Requirements: A Case Study

EU MDR: Your Questions, Our Answers

Regulatory and Quality Solutions Names Julie Maes Director of Territory Operations – Northern Lakes Region

The Lowdown on Cybersecurity for Medical Devices

[Free R&Q Webinar] Cybersecurity for Medical Devices: The regulatory and quality ramifications.

RESOURCE: The MDR and IVDR Have Been Published! See Our Table of Key Dates

MEDDEV 2.7/1 & CERs: Know the Changes and What to Do [Webinar]

EU MDR and Clinical Evidence: What You Need to Know

EU MDR: Assessing the Impact and Next Steps [Webinar]

MDSAP: A Better Inspection Option for Device Manufacturers?

MDSAP: What is it? Is it for me? How will I get it done? [Webinar]

Review Controls Applied to Outgoing Data Streams (Because the FDA Might Be)

NEWS: Bill Introduced to Improve FDA's Medical Device Inspection Process

A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015 [Webinar]

Acquisition Regulatory Assessments: A Case Study

R&Q Q&A: Minnesota Spotlight

Regulatory and Quality Solutions (R&Q) Certified By the Women’s Business Enterprise National Council

A Cool New Way to Prevent Cancer Hair Loss — Literally

Headway in PA: Announcing Dedicated Operations Directors in Pittsburgh and Philadelphia

Process Validation Case Study: Know What You Know... and What You Don't

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

Slides and Webinar Recording: Chemical Characterization Requirements

Next Up: FDA Regulatory 101 with Combination Products Spotlight at Heal Ohio Conference

Master 510(k), IDE, and PMA Submissions at AdvaMed's Workshops

CAPA on CAPA: Webinar Slides and Recording

The REdI Fall 2016 Conference: Slides and Recordings

Free Webinar: Chemical Characterization Requirements: ISO 10993-18 and Extractables & Leachables Requirements

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

Minnesota Momentum: R&Q Hires Member of ISO Technical Committee 210, Mark Swanson

Revamping Supplier Quality: A Case Study

When CAPA Needs a Corrective Action: A CAPA Remediation Case Study

Medical Device Development: Avoiding Pitfalls in Human Factors / Usability and Design

Med Device and Med Tech Startups: Master Regulatory Basics and More! September 22 in Philly

5 Reasons Not to Fear a Supplier Audit

What You Should Do About the Two New FDA Draft Guidance Documents

Free Webinar: CAPA on CAPA, Presented by MassMEDIC and R&Q - Register Now!

R&Q's Christine Santagate Featured in Medical Design & Outsourcing

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

Wearables are Exploding (Not Literally!) and Transforming the Medical Device Industry

10 Tips for Adopting the Updated ISO 13485:2016 Standards: Webinar Slides and Recording

FDA Approved: A Human Factors and Usability Case Study

4 Things R&Q Learned At MD&M East

This New Med Device Will Help You Sleep Better

Industry Advice: Earn RAC Points and Enhance Your Resume by Writing for RAPS' Regulatory Focus

R&Q Q&A: Boston Employee Spotlight

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

R&Q: Engineered by Women

A Whole New World of UDI: Slides and Recording

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

Presentation and Networking at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems (BEING RESCHEDULED)

The New ISO 13485 Standards are Here! Sign Up for a Free R&Q Webinar

AdvaMed Workshop: Integrating Human Factors into Med Device Design Control and Beyond

MassMEDIC Webinar: A Whole New World of UDI - May 18

PA Bio Connect@ - May 9 in Philadelphia

AdvaMed Webinar: Avoiding and Managing FDA Compliance Problems - Monday, May 9th

NEW White Paper - Practical Considerations for Avoiding Regulatory Escalation: R&Q's Latest, In-Depth White Paper from a Former FDA Consumer Safety Officer

Minnesota, Here We Come: See You at the 2016 Medical Alley Annual Meeting, April 27th

R&Q's Can't-Miss Education Event of the Year: An Afternoon Training Workshop at BIOMEDevice in Boston, April 13th

When Benefit Outweighs Risk: Creating a Successful Clinical Evaluation Report - A Case Study

5 Heads are Better Than 1: De-Risking Your Regulatory Pathway Using a Team Approach - A Case Study

Introducing Our First In A Series of New R&Q Case Studies: Design History File Remediation

Announcing the 2016 FDA Regulatory 101 Series

Hear R&Q and Other Industry Experts Discuss 510(k) Submissions at AdvaMed's Workshop In Irvine, CA

Revisiting a Classic: The Pirate-Themed CT Scanner

R&Q Is Sponsoring The M2D2 $100K Challenge and A Summary of Important Dates

Presentation and Networking: Is A Medical Device Hiding In Your Product Portfolio? Join R&Q at MassBio!

Announcing R&Q's Newest Senior FDA Compliance Principal: Former FDA Consumer Safety Officer Jake O'Donnell

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

Welcome To R&Q's New Website!

Notified Body Expectations: Today, Tomorrow and into the Future

Ten Tips for A Successful Use of Total Product Life Cycle (TPLC) Reports

Ten Tips for Successful Integration of Risk Management & Usability Engineering

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

Successful Regulatory Strategy-Ten Tips

CAPA - Best Practice Sharing

Implementing a Successful Recall Process - Ten Tips

Warning Letters - Ten Tips

Pre-Submission Program – Final Guidance

Affordable Breakthrough Innovations

Guidance Documents for 2014

Pediatric Subpopulations – Final Rule

510(k) Pop Quiz!

3D Printing in Medicine

Regulatory News - Report on FDA Device Review Process

Transhumanism - Science from Fiction: Conclusion

Devices for the Military

Veterinary Medical Devices - FDA Regulations

Transhumanism – Science from Fiction: Part III – Not So Vulcan Mind Melds

Getting to Know You

Transhumanism - Science from Fiction: Part II - Rise of the Cyborg

Devices remain unclassified

A Culture of Quality

Not-So-Blind Ambition

RAPS 2013 Series: MDSAP

Quality Control for Blood Transfusions

First Artificial Pancreas receives FDA Approval

On the Edge of Our Seats

Deep Breaths

Government Shutdown - Impact on Medical Devices

Transhumanism - Science from Fiction: Part I - Bionic Body Parts


FDA gives Voice to the People

RAPS 2013: Education Series

License Amendment Triggers in Canada

Pounding the Pavement

R&Q at RAPS 2013!

FDA Releases Mobile Medical Applications Guidance Document

Retraining the Brain – A New Approach to Treatment for Schizophrenia

UDI Documents Released by FDA

EU marketing approval system

India Medical Device Labeling

Same Road (Regulatory Pathway), Different Car (Medical Device)..Similar Success (Clearance,Approval)

Transhumanism - Science from Fiction: Intro

International Labeling Requirements

Foreseeing the Risks

510(k)-Exempt Devices

Personalized Orthopedics

FDA guidance document on RF Wireless Technology in Medical Devices

Improved machines based on human biology

Recognition for Contributions in Medical Advancement 60 years in the making

Reliability – From Bike Racks to Medical Devices

Vacation Revelation

Mobile Medical Applications - Most Reliable Apps, Internationally?

Fear Factor: Audits

Device Idea to Staying Power in the Market

RQS Ohio Social Event - August 14, 2013

Guidance document clean-up! - CDER

Draft Guidance on Medical Device Reporting for Manufacturers - Issued 07/09/13

Super Supplements or Scary Supplements: Consumers are the Judge

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

Just Say No

FDA Medical Device Reporting Update

How the FDA handles complaints

Mobile Medical Applications: Make Sure uChek with FDA

Documentation 101: Life as an Engineer

Croatia Joins the EU

A Vaccine for Colon Cancer

The Importance of Production Equivalence


My Day at FDA

FDA Inspections Database

Funding Your Start-Up Medical Device Company

Congenital Heart Walk

Regulatory Intelligence

Eye Spy

Consumer Medical Device Adverse Event Reporting

Integration Phase - AGILE vs. Regulatory

Race for the Place and RQS Cares

510(K) Success!

Mobile Medical Applications - More Apples, More Hassles

FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device

Complaint Handling Solutions

Medical Cybercrime

Internal Audits, the After-Thought of a Quality System

Using AGILE in Medical Device Software Development

MedCon 2013

Why RQS Cares - Congenital Heart Walk

Localization Issues

Training, a Test of Endurance

Why RQS Cares - The Race for the Place

When Will Academia Catch-up to the Needs of the Medical Device Industry?

Who’s watching your MedWatching?

Everyday Usability – Alarm Clock Edition

New Biocompatibility Draft Guidance

Crash Those Symbols - FDA Proposed Rule

Proposed Order on AEDs

RQS Cares - Congenital Heart Walk

RQS Cares - Race for the Place

Quality Systems Becoming the Culture of a Company

Crowd Source in Medical Devices?

Human Factors

Patent Law Changes

An Alarming Trend

FDA's Guidance of User Fees and Refunds for Premarket Notification Submissions 510(k)s

FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

Audit Training

Medical Device Development: Trades

Bipartisan Repeal of Medical Device Excise Tax

Medical “Wow”: 3D Printed Skull

March Madness

RQS Feature Article - Successfully Addressing Warning Letters

HFES Health Care Symposium – What’s New in Human Factors and Usability?

Getting Control of Supplier Controls

RQS appears in TEQ Magazine

Latex and DEHP and BPA, Oh my!

Make Sense

FDA issues draft guidance for accurate labeling on medical products that are not made with natural rubber latex

Keeping Up With Regulations

Autonomy with Boundaries

FDA Budget Cuts This Week

Architect of Quality – Part 4: The Juran Quality Trilogy

Open Comments are Not Left Unheard!

Regulatory Science

Technology Overkill?

Go Ahead, Take a Chance

Regulatory Thoughts

New Medical Devices Coming Soon to a Hospital Near You

Architect of Quality – Part 3: The Pareto Principle

Cleveland Rocks… its way to the top five growing life science hubs

Curling Nationals!

A QMS Outcast: Preventive Action

Making Sense of Standards


Auto Compliance

Thoughts About Auditing

Would you like fries with your Combo meal?

Final Rule - Combination Products

Architect of Quality – Part 2: The Human Dimension

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

Mobile Medical Applications - Where do we go from here?

Who is your customer?

Small Label, Big Impact

Some Things Never Change....

Medical Devices and Fantasy Football, More in Common Than You Think

Regulatory Intel - Jan. 21, 2013

Hitting Home

Architect of Quality - Part 1

Identification... Unique Device Identification.

Regulatory Intel - Jan. 14, 2013 Quick-Hits

Mobile Medical Applications - Healthcare at CES

New "Refuse to Accept" Guidance Document for 510(k)s

Location, Location, Location

Be Smart: Look Smart

The Promise

Quality Lessons of a New Parent

Mobile Medical Applications - Only a Bandage?

New Year, New Resolutions

A Fresh Start

Holiday Anecdotes

Regulatory Intel - Alerts, Updates, Newsletters

Unwanted Gifts

Mobile Medical Applications - Progress?

Heart to Heart

Mistake, I Think Not!

Biodegradable Circuits

Astronaut Icecream and Medical Devices

Labels impact the device

Call me a (Juris) Doctor!?

Setting Precedence

Biocompatibility - Simple, Right?

In Your Face

What is the Medical Device Excise ?

Quick Hits - December 11, 2012

Mobile Medical Applications - Community Bull-Dozers

New Heights in Prosthetics

United States v. Caronia

Women in Bio Success!

Mobile Medical Applications - Beam Me Up, Scanadu

Deals and Steals

International Spotlight - China

No Time for Common Sense

Can't we just all get along?

Balancing Act

Doctor Mario to Surgery, please… Doctor Mario to surgery

Truth Behind Facts

Women in Bio - November 29th Kick-off Event

Mobile Medical Applications - Call Security!

Regulatory Intel - Government Databases

Exploding Bombs?

Set Phasers on Stun

Success as an innovator

Rethinking Innovation

Mobile Medical Applications - Aycan 510(k)

When the Lights Go Down in the City

Stay out of Frying Pans and Fires!

Innovative to the Bone

Lessons of a High School Speech Geek

Searching for Medical Device Info

Mobile Medical Applications - Difficult Usability?

Training and a couple jokes

Left Wing, Right Wing, or Somewhere in Between

Need a Hand?

Conducting a Literature Review

Overview of New Medical Device Regulations in Europe

Blast from the Past - Everyday Usability

Mobile Medical Applications: Titanic Chairs

October brings awareness to women’s health issues

User Research Methods

Great Lakes Venture Fair

Keeping up with Standards

Mobile Medical Applications: Whale Cupcake

Blockbuster is no more - A discussion on disruptive technology

The Change Agents

Spider silk isn't just for Spider-Man

Medical Devices in Different Markets

Medical Device Tax: Funding Healthcare for Millions

Devices Regulations in Europe

Now that’s some real horse power

Moderating Usability Testing

Medical Device Tax: Windfall or Pitfall?

Creating Consistency

Navigating Substantial Equivalence

Mobile Medical Applications: Mobile Medical Device Design

More changes heading our way?

RQS on YOUR Airwaves

Mobile Medical Applications: Innovation vs. Regulation

Real Service


Medical Device Design for Cross-Cultural Use

Mobile Medical Applications: Falling Star?

Networking Success!

Unexpected Benefits

Setting Realistic Expectations of Medical Device Users

Networking with Technology

Mobile Medical Applications: Five or One Galaxies in the Lumia Nexus?

Standing Out vs. Fitting In

Cleveland, We Have a Problem

Healthcare going mobile

Creating Growth and Improving Performance

RQS on the Airwaves!

Death and Taxes

Success Rates for Usability Objectives

Nano-what? Nanotechnology.

Becoming a Successful Consultant

PTC Breakfast Briefing on EU Market

FDA Releases Mission, Vision, and Shared Values

What's taking so long?

FDA: Jekyll or Hyde?

Defining Usability Objectives

Walking like an Egyptian

RQS Honored With Tech 50 Nomination

An Idea Around Innovation

RQS Rises to Top of Pittsburgh 100

RQS in the News - Cleveland Office Opening

FDA ISO 13485:2003 Pilot Program

Upcoming Webinar - Common Mistakes for Medical Device Startups

Kim Platt joins RQS as Principal Specialist

Lori Smith-Sakalousky joins RQS as Principal Specialist

Mobile Medical Applications: Wellness Apps

Mobile Medical Applications: Visual Calibration

Mobile Medical Applications: Cyber Security

Mobile Medical Applications: What's App-ening?

Everyday Usability 14

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

Everyday Usability 13

Making Sense of the FDA's 510K Program

Everyday Usability 12

"Cheap" Microscope Anyone?

Incentive-Based Regulation: Is it possible?

Everyday Usability 11

Improving Device Human Factors Through Focus Groups

Acne Apps Dried Up by FTC

Everyday Usability - 10

Disney's Root Cause Analysis?

EN 62304 Certification?

Everyday Usability 9

RQS Nominated for 2011 Best Places to Work

FDA Issues Draft Guidance for Clinical Investigations

Everyday Usability 8

FDA Regulation Goes Mobile

Everyday Usability 7

PBT Article on RFID Tagging Quotes VP Casavant

Jyothsna Nunna joins RQS as Staff Quality Engineer

Beth Freed joins RQS as Senior Regulatory and Quality Associate

Everyday Usability 6

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

Everyday Usability 5

Scott Wright joins RQS as Principal Regulatory and Quality Advisor

MDDS Regs Change, Provide Insight for Future Changes?

Everyday Usability 4

Everyday Usability 3

Everyday Usability 2

VP Casavant featured in Pittsburgh Business Times

Picture Series - Everyday Usability 1

Pittsburgh Business Times Featured Article

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