This is not exactly what you asked for, but I thought you may be interested.ģ.1. I see a Quality Manual revision and process change on the horizon. ![]() The customer base seems to be changing their requirements (especially the last month or so) and some will now start requiring more info for validation and risk analysis, which means they will be providing more information to me to help in this effort. Up to this point, our Risk Analysis has been limited to the section below as found in the quality planning process. We are a tier 1 contract manufacturer for orthopaedics. Re: ISO 13485 Clause 7.1 Planning of product realization - Risk management
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