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  • Hi, I'm selling my RAPS Fundamentals of US Regulatory Affairs (Ninth Edition). Besides some highlighting and notes, the book is in good condition (see pictures). Let me know if you are interested ! Price is to be discussed according to shipping fee. I'm located in Montreal (QC), Canada. ------------------------------ Maria Laitenberger, Jr. Eng., ...

  • Hi everyone, Does anybody have experience with ISO 8185:2007? I have a question about section 51 and would appreciate if I can privately message somebody with experience. Thanks! ------------------------------ Virginia Anastassova RAC RA Manager, Senior QA Specialist Starfish Medical Victoria BC Canada ------------------------------

  • EN50581 guidance document was released to clarify Technical Files requirements related to RoHS directive 2011/65/EU. I hope this helps. ------Original Message------ I'm going to be doing a RoHS compliance audit for a series of medical devices for Europe. The 2011/65/EU indicates a need for technical files. What does the community ...

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