Dear Experts, To fulfil the requirement of ANDA Submissions -Content and Format guidance from FDA we are providing below documents in 3.2.P.8 sections - 3.2.P.8.1 Contains the stability summary and read more
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 read more
Join Novotech for a CTIS webinar. Ensure a seamless transition and compliance by January 2025! โ Regulatory Affairs Professionals Society (RAPS) San Francisco Bay Chapter is honored to be invited to participate read more
This message was posted by a user wishing to remain anonymous Hello, everyone, I am seeking insights or experiences from peers who might have dealt with a similar situation. We currently sell our medical read more
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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 ...
This message was posted by a user wishing to remain anonymous Hello, everyone, I am seeking insights or experiences from peers who might have dealt with a similar situation. We currently sell our medical device non-sterile in the UK. However, due ...
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 ...
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