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Thank you all for your guidance Craig ------------------------------ Craig Jolicoeur RA/QA Manager San Marcos CA United States ------------------------------

Hi All, I see in MDSAP (Chapter 1 Section 5) that Canadian distributors need to be qualified as suppliers and controlled, as appropriate. It is not as clear if distributors in Australia, Japan, and Brazil also need to be qualified as suppliers. Does anyone have any experience with an MDSAP audit ...

Thank you Lee.  Greatly appreciated. ------------------------------ Craig Jolicoeur CMQ/OE, CQE Quality and Regulatory Manager San Marcos CA United States ------------------------------

Are you creating these 'combined' TFs for just easier document control? Yes And thank you for the additional information. Craig ------------------------------ Craig Jolicoeur CQE Quality and Regulatory Manager San Marcos CA United States ------------------------------

Hi  I am revising our Technical File for a Class IIa family of products in the EU that are Class III in Canada.  I would like to have one file for this family that covers the EU and Canadian TF requirements. My initial though was to revise to BSI's "Medical Device Documentation Submissions Best Practice ...