R&Q's Blog

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


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


Within driving distance to D.C.? There's still time to enjoy a few days there next week and simultaneously hone your submissions skills. The FDA, R&Q, and other talented industry experts courtesy of AdvaMed are offering three workshops dedicated to teaching you the guidelines for successful 510(k), IDE, and PMA submissions. Engage in interactive workshops and hear from industry professionals - such as R&Q's Director of Regulatory of Affairs Nancy Morrison and Senior Principal Advisor Marilyn Waxberg. The AdvaMed events are some of the best in the business, and R&Q is proud to be included as part of the faculty. Read on for details! 

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

Attention any and all regulatory affairs specialists, engineering managers, quality & production engineers, QA/Q directors and managers and compliance officers: AdvaMed is presenting a Design Control-focused workshop in Golden Valley, Minnesota, June 7-8. The workshop has been pre-approved by RAPS as eligible for up to 9 credits towards a participant’s RAC recertification upon full completion. R&Q's Bob Marshall (pictured) and Ryan Kasun will be on hand to present. Read on for more details and to register!

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.

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

Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other industry experts at AdvaMed's 510(k) Submissions Strategy Workshop in Irvine, CA this month. The event is scheduled for two days: February 22-23.

Marilyn is R&Q's Senior Principal Advisor and Nancy is Director of Regulatory Affairs. Nancy will be speaking to The Law and Regulations portion of the agenda alongside Pamela Forrest of international law firm King & Spalding. Both Marilyn and Nancy will be leading the Strategy and Planning section on day two.

FDA Budget Cuts This Week

This week, the FDA faces between 5.1 to 5.3% of their budget being cut this week ($210 million of a $4.1 billion budget). I’ll be interested to see what areas of the FDA are impacted by these budget cuts, and what that means for medical device manufacturers. Proposed to be included in those cuts are the user fees medical device & pharmaceutical companies pay the FDA for timely reviews of new medical devices & drugs. Zimmer’s CEO and AdvaMed chairman David Dvorak announced during a conference “The fees voluntarily paid by industry in exchange for meeting certain performance goals are not tax payer dollars and should not be considered in the same light as appropriation funding”. March 1st marks the deadline for when or if these budget cuts will be passed.

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