Increasing acceptance of the standard by employees and management,.Bringing relief to medical device industry and free-up resources heavily needed for new product development and/or improved patient safety,.We have to remind ourselves that ISO 13485 originated from the voluntary standardization scheme of ISO 9000 and still includes many clauses which are not related to patient safety or product effectiveness. ![]() As we are continuously getting more restrictive and detailed regulations in most jurisdictions, the importance of a detailed QMS standard for medical devices is decreasing. The more I am auditing and the more I am being audited my conviction is growing that ISO 13485 must be simplified significantly.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |