on 28 June 2013 | By Ryan Kasun
My recent work has involved providing regulatory assistance to software medical devices. One thing I have been learning about is how security and privacy is handled with these types of products. Often times I have experienced clients grouping regulatory affairs with privacy and...
Read Moreon 25 April 2013 | By Ryan Kasun
FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1...
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