Please note that the regulatory pathway for marketing a sterile device has extensive requirements for validation of the sterilization process, validation of the package and validation of the product functionality read more
Hello Anon, Indeed there are medical devices which are sold non-sterile and sterile which are the same configuration/same product - sometimes with certain types of implants. They are offered in sterile read more
Hello Anon, There is only "one" cycle for PMA on a regular submission. So once the 180 days elapses and deficiencies not met, then it would end up not being approved. Again, there are quite a few discussions, read more
I have some pharmaceutical companies as clients, although I am still working with medical devices. I have to explain again and again that: Medical devices live in a different universe compared to medicinal read more
Hi Olga, Thank you for your interest. I'll message you. Yoshiko ------------------------------ Yoshiko Stowell Fremont CA United States ------------------------------
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Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering in medical device development, transitioned into a JIS standard in 2019 and was updated as ...
Join Novotech for a CTIS webinar. Ensure a seamless transition and compliance by January 2025! Regulatory Affairs Professionals Society (RAPS) San Francisco Bay Chapter is honored to be invited to participate in this webinar with Novotech ...
Join Women In Bio Capital Region and the University of Maryland School of Pharmacy for an exploration of strategies aimed at risk mitigation, implementation, and evaluation in healthcare products. Our esteemed panelists will provide invaluable insights ...
The 2024 RAPS award nomination process is open , which means we get to focus on t he individuals who have made significant contributions to the profession's advancement. Know someone who deserves to be nominated? Learn more about the RAPS ...
This message was posted by a user wishing to remain anonymous Hi! I've been struggling with the following consideration: For Section 3.2.P.1 for a BLA or MAA - do I need to include two tables for a drug product that is reconstituted or diluted i.e. ...
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