R&Q's Blog

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

 

MDSAP: A Better Inspection Option for Device Manufacturers?

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. Please join us for a free one-hour webinar on MDSAP, March 28th.

Medical device firms, are you looking forward to your next FDA inspection? I have conducted around 400 of them, and I am still trying to think of an instance when the firm was happy to see me. I never took it personally. FDA inspections can be stressful, not to mention they are very expensive and time consuming to support. Furthermore, FDA inspections are often followed by an unpleasant period of uncertainty regarding outcomes and adequacy of responses.

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

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: April 25th, where we'll discuss EU MDR.

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