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Another point occurred to me. You will not have any process changes as a result of appointing a PRRC. For each area of responsibility, you currently have somebody who does it and somebody who ensures it is done. Those processes should not change. While there are many ways for the PRRC to exercise the responsibility to ensure, I think the best method ...

Dear Pomme I assuming that I am in a different position since I am an employee with MedTechXperts, not a legal manufacturer.  Since my business, MedTechXperts offers consulting services, including supporting the PRRC position, we were advised by a lawyer to have liability insurance which would cover this role. Other consulting firms have informed that ...

I use TimeClock, since my needs are simple, and the app works well for me. ------------------------------ Maninder Chopra PhD Frederick MD United States ------------------------------

Hi, To simply answer your question... NO, your QMS does not need to be certified, period.. if you have labs, those always have to be certified. An FDA auditor won't care about your ISO certification. They will check to see if you QMS is compliant with 21 CFR 820. However, having your QMS certified by an agency is highly recommended.  Hope this helps. ...

On US Thanksgiving day, 2 gifts from China NMPA (CFDA) to help overseas manufacturers: "Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)" (No. 77 of 2020)    "Technical guideline for overseas clinical trial data usage in vitro diagnostic reagents (draft for comments)". Both guidelines ...