R&Q's Blog

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


Slides and Webinar Recording: Chemical Characterization Requirements

Missed our webinar with iuvo BioScience - Chemical Characterization Requirements: ISO 10993-18 and Extractables & Leachables Requirements?

Good news: you can now download the slides and view the recording.

CAPA on CAPA: Webinar Slides and Recording


Missed our CAPA on CAPA webinar with MassMEDIC? Now you can download the slides and view the recording.

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


This joint webinar presented by Regulatory and Quality Solutions (R&Q) and iuvo BioScience is focused on the requirements for chemical characterization in the healthcare industry. Specifically, it will discuss the standards required for ISO 10993-18 chemical characterization for medical devices and compare the ISO requirements with the pharmaceutical industry requirements and best practices for extractables and leachables testing.

The goals for this webinar are to explain the standards for both industries, discuss the testing methodologies required, and provide some case study experience from an E&L perspective. You can register here.

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

We all gotta start somewhere... and Pennsylvania Bio and Quorum have helped us put together an invaluable event to help your early-stage medical device company hit the ground running. Seasoned experts, such as R&Q's President Maria Fagan and Buchanan Ingersoll & Rooney's Will Garvin will be presenting content and answering any and all of your questions and curiosities (you have the chance to submit them in advance during registration).

The Regulatory 101 for Medical Device And Med Tech session is September 22 in Philadelphia and we encourage you to register early!

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

CAPA is often overlooked as an integral component of a quality system. More often than not, the FDA can trace deficiencies in a system directly back to the CAPA system. However, an effective quality system needs more than just a rework of the outcome of the ineffective CAPA system. It needs a rework of the system itself. 

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

■ ■ ■ Are you an Ohio Bioscience Expo & Showcase attendee here to register for the FDA Regulatory 101 Series? ■ ■ ■

Register Here


The Ohio Bioscience Expo & Showcase and next FDA Regulatory 101 Series event are on July 27th and 28th, respectively. If you're outside of Columbus but in Ohio, you're likely close, and there's no better time for a road trip than the middle of summer! In fact, here are drive times to Columbus, OH from some nearby cities:

Cleveland: 2 hours 9 mins
Cincinnati: 1 hr 41 mins
Toledo: 2 hr 29 mins
Akron: 1 hour 55 mins
Dayton: 1 hour 5 mins
Canton: 2 hours 2 mins

If you can drive to Columbus, OH in a single day, the only thing between you and R&Q on July 27th and 28th is a little open road. Below are all the details you need to know and be sure to save your seat for the FDA Regulatory 101 Series event!

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

Missed our latest webinar on this year's ISO 13485 changes? Now you can download the slides and recording.

R&Q's Director of Regulatory Affairs Nancy Morrison and Client Solutions Advisor Christine Santagate walked through 10 tips for adopting the latest changes. From conducting a gap assessment and creating a quality plan to modifying procedures/processes and auditing, they communicated industry best practices to help those in the industry confidently take the next steps in their process.

A Whole New World of UDI: Slides and Recording

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

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

Be a part of the largest and most influencial medical manufacturing event on the east coast. Join more than 500 leading medtech suppliers and manufacturers - including Johnson & Johnson, Stryker, and countless others - at the Medical Design & Manufacturing (MD&M) East Expo and Conference, June 14-16 in New York City. Needless to say, the R&Q team wasn't going to miss this and we'll be on hand at booth 1164 and ready to listen to what's happening at your organization.

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

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


Regulatory and Quality Solutions (R&Q)


A presentation and networking event over lunch at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems, and How to Manage Them If They Arise
In the session you will learn from a former FDA consumer safety officer of 20 years what it takes to proactively improve your systems to avoid problems, and proficiently manage issues if they happen to occur. First-hand experiences of how R&Q helped remediate projects will be shared, and best practice strategic and tactical solutions will be given for how to avoid those situations in the first place. We’ll also investigate emerging oversight trends, common problems, classic times in business cycle when compliance issues arise, and other specific challenges.

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