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    Scope of MDSAP

    Hello,  I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the ...

  • Is anybody interested in forming a study group for the RAC Devices Certification (Spring 2020) ? I am located in Minneapolis and am looking for study partner(s) who can discuss and plan the study schedule. If anybody is interested please write to me on ppatil1209@gmail.com  Thanks Poonam ------------------------------ Poonam Patil Little Canada ...

  • Anon, Agree with Michelle's approach - that's one way to do it. But there are times when a pre-IND meeting is sought and the sponsor may eventually decide not to proceed with an IND at all. Typically small organizations may also lack publishing resources and once you are making submissions to an IND (if you request an IND number), you have to submit ...

  • Yeah, this clearly isn't that kind of question (i.e., the kind that a newbie might shirk from asking nor the kind that reveals information about a company or its products.)  It isn't even a regulatory question. ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Mebane, North Carolina, ...

  • Many take contract manufacturing as granted since western countries have done this for decades. But it was a different story in China. Companies had to be certificate holders and, at the same time, manufacturers, until January 5, 2018 when Shanghai became the first Market Authorization Holder (MAH) piloting city. Later Tianjin and Guangdong were added ...


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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