This procedure package includes two documents
1. Post-market surveillance procedure
Purpose – The purpose of this (6)-page procedure is to provide for systematic data collection, analysis, reporting and review of information about the safety and efficacy of products that have been released to the market.
Scope – This procedure covers all products that have been transferred from product development to post-market surveillance. This is the primary document meeting the applicable regulatory requirements for Post-Market Surveillance, and a supporting document for Risk Management, as defined in your company’s Quality System Manual…
2. Post Market Surveillance (PMS) Review Program form
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