FDA PMA Critical to Quality Pilot Program

Participation in the PMA CtQ pilot program is voluntary – the program aims to evaluate device design and manufacturing process quality information early on to assist the FDA in its review of the PMA manufacturing section and post-approval inspections. This voluntary pilot program is part of the FDA’s ongoing Case for Quality effort to apply innovative strategies that promote medical device quality, and is a joint effort between the FDA’s CDRH and Office of Regulatory Affairs (ORA). The program is intended to provide qualifying PMA applicants with the option to engage the FDA on development of CtQ controls for their device and forego the standard PMA pre-approval inspection. FDA would in turn, focus on the PMA applicant’s implementation of the CtQ controls during a postmarket inspection. FDA is seeking companies to volunteer to participate. Full information is at the link provided. Premarket Approval Application Critical to Quality Pilot Program

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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