R&Q's Blog

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


What You Should Do About the Two New FDA Draft Guidance Documents


It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, it finally happened! For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.

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

If you missed R&Q's Paul Robinson discuss UDI during R&Q's afternoon workshop at BIOMEDevice in April, here's a second chance. A similar presentation and discussion will be offered in conjunction with MassMEDIC on Wednesday, May 18th at 11:30am EST. All the details - including the link to register - are below!

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

Did you miss former FDAer Jake O'Donnell speak about avoiding and managing FDA compliance problems during R&Q's afternoon workshop at BIOMEDevice earlier this week? If so, we have news especially for you: he will be presenting on a similar topic via a webinar on Monday, May 9th at 1:00pm EST. The webinar is presented through AdvaMed, and all the details - including a link to register - are below.

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

There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper shares it. Learn all the practical considerations for avoiding regulatory escalation from a former FDA Consumer Safety Officer: R&Q's Jake O'Donnell. This is your free, ultimate compliance resource, that you can download now:
Managing An Adverse FDA Inspection: Practical Considerations for Avoiding Regulatory Escalation.

Preview the first four pages of the 24-page white paper below (click to enlarge), and download it in its entirety at the link! We hope you find the white paper valuable. If you do, be sure to share it with your colleagues and industry peers. Subscribe to R&Q's Blog to stay updated on when new white papers and other content is available.

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

Those in the northeast, get ready! Not only will R&Q be exhibiting at this year's BIOMEDevice show (booth 640) and sponsoring MassMEDIC's Annual Conference, but we'll be presenting an afternoon training workshop (three separate sessions) free to attendees of the BIOMEDevice show on Wednesday, April 13th from 1:00 - 4:00pm. The event will cover compliance, IVDR, and UDI... and you can choose to attend whichever session(s) you like. This will be one of R&Q's premier education events of the year and we're incredibly excited about the team we'll have on hand to share their expertise and experience, moderate discussion, and field questions. Keep on reading for complete details.

India Medical Device Labeling

This week I will provide some information about labeling in India. CDSCO (Central Drugs Standard Control Organization) regulates the medical device industry in India. Only medical devices that CDSCO has put in the “Notified Devices Category” require registration. There are very few product types on this list and they are regulated as “drugs”. Registration is not required for import of non-notified medical devices in India. Please refer to the link below for a list of the notified device categories that must be registered in India:

Internal Audits, the After-Thought of a Quality System

Why is it that Internal Audits are forgotten, or even worse feared? Why is it so many organizations of today place so much focus on the creation of Quality Procedures, Work Instructions, Forms, etc. but do not place the same focus on conducting internal audits of the quality system? Is it human nature? We all tend to be "gung-ho" about projects at the start, but the passion, and therefore the quality of the work, so often deteriorates over time.

Auto Compliance

Coming to your commercial break at the 2014 Super Bowl at Met-Life Stadium - the automated compliance robot!

Thoughts About Auditing

'Tis the season for auditing. The beginning of this year, just like years in the past, seems to have brought the New Year's Resolution that audits will be scheduled and conducted to correct the sins of the previous year and take a fresh look at the upcoming year. To this point I've conducted three audits and after this week I'll have been the auditee twice (essentially an audit per week to start the year).

Keeping up with Standards

With recent clients I have been dealing more and more with new standards coming out or revisions being made to standards. This has got me thinking a lot about how to keep up with current standards. What is the best way of being notified of new releases of standards as well as interpreting and then implementing those standards?

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