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  • Hi , When FDA extended the compliance dates for UDI for Class I devices , it mentions the exemption is for CGMP exempt devices . What does this mean ? Thanks & Regards, Rashmi Pillay Regulatory Affairs Associate Ellex 3-4 Second Avenue Mawson Lakes SA, 5095 T + 61 8 7074 8105 ...

  • A Few Spots Still Open for ASQ Event Join the ASQ Salt Lake Section for an exclusive look inside a local medical device manufacturer's facility! A Tour of Maxtec - September 28, 2017 5:30 pm to 7:00 pm Attendees will experience a 45-minute tour of Maxtec's manufacturing and operations and then convene for food/refreshments and a 30-minute ...

  • Dear All, thank you very much for your replies. They were all very helpful. I would like to ask Al about any reference to the second point (discontinue of distributing some medical devices), if there is any regulatory reference which can support this evaluation, which I also share. Any information is very much appreciated. Thank you! Kind regards, ...

Rainer Voelksen, FRAPS, Talks Volunteering and European Advisory Committee

"Regulatory professionals need to hear the voices of those working in other countries. Just helping others to get used to hearing other languages is important, and you can be a cultural representative at the table in any stage of your career. The regulatory industry is increasingly global, but all regulators work differently. We must all work harder to become comfortable sharing information in an international space so that the industry can successfully continue to develop."

Rainer Voelksen, FRAPS


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