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  • Hello, Are you looking for MDR in french? Here is the link: https://eur-lex.europa.eu/legal-content/FR/TXT/HTML/?uri=CELEX:32017R0745&from=FR Several MDCG guidances are referenced by the frech agency but they are in english. See MDCG websites https://ec.europa.eu/growth/sectors/medical-devices_fr This is a PPT from ANSM reagrding the MDR implementation: ...

  • Hello, Hereafter, extracts from federal register. Hope it will help S 11.300(b) addresses periodic Issuance changes to ensure against their having been unknowingly compromised. This provision would be met by ensuring that people change their passwords periodically. For Password aging: The agency cautions, however, that the example should not ...

  • Notification of Examination Results Examination results are typically available four to six weeks after the close of the testing cycle. The spring testing cycle closes on 31 May and the autumn testing cycle on 30 November. You will receive an email notification with your pass or fail results. Approximately four to eight weeks following the close of ...

  • OK, so I just realized you are talking pharma, not medical devices, so neither 21 CFR 820 or the IDE regulations apply  The IND also exempts investigational drugs from pretty much the same types of requirements, but if the study is a postmarket study that is not being conducted under an IND, that's irrelevant.  Hopefully a drug RA specialist can tell ...

  • Hi, It is probably not helpful to seek to find guidance documents to argue against your NB.  It's best to speak with them, and to seek to find a solution with them. Have you provided a root cause analysis for the current NC? Are you able to correct the NC immediately?  Do they have reasons to believe that the issues similar to the present ...


Volunteer Appreciation 2019

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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