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Anon, This is a "must do" exercise medical device manufacturers need to go through and there can be many different ways to do this. It can be from having a couple check boxes on a component specification, ...
Good day Anon, Without seeing the exact shipping path and transactions occurring - based on the information provided, yes this is ok. In fact, shipping products within the European Union is quite ok ...
Anon, There is not really any guidance out there - I gave a presentation concerning this at RAPS Euro Convergence in 2023 so might be able to find some "white paper" information. I would not have a template ...
Ciao Marisa, sarò anch'io al RAPS Euroconvergence. Ci vediamo a Berlino! Marta ------------------------------ Marta Carnielli TUV SUD Product Service GmbH München Germany --------------------- ...
Hello Folks, I have 21 years work experience in QA&RA function, and 14 years work experience in MNC medical company as a QA/RA Supervisor/ Manager/MR. The headquarters are located in EUROPE / USA. My ...
China NMPA also creates the searchable database open to public: 国家药品监督管理局医疗器械唯一标识数据库 (nmpa.gov.cn) ------------------------------ Minghua Chen BD Manager, APAC Qserve Group (China) Nanjing China --- ...
Yemi Ijose Regulatory Affairs Senior Manager ... More
Hi Everyone Just a reminder we will meet this week at 3 pm to 4 pm on Friday. I will present Chapter 8 of EU, from the 5th edition of the RAPS ... More
This message was posted by a user wishing to remain anonymous Hello, I am working on updating Module 3 sections for an IND as we are beginning Phase ... More
This message was posted by a user wishing to remain anonymous We plan to send out a Dear Dr Letter to notify investigators of a new safety event for ... More
You are making a presentation to the senior management team. You announce that there is no way that the FDA will clear your device in less than 120 days. ... More
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