The German Association of Medicinal Product Manufacturers (Bundesverband der Arzneimittel-Hersteller - BAH) provides i.e. updates for its member companies supporting sample documents with regard to GMP applications. These sample documents are very useful and are primarily aimed at manufacturers of medicinal products. Yet, there are also sample SOPs for medical devices. Results of the risk analysis for marketed products are an essential part of the technical documentation of medical devices. In this respect, risk assessment is a crucial component in a medical device's life. One of the possibilities to perform a risk analysis is the FMEA. For this method of risk assessment, the BAH has released an example of a risk management SOP "Performance of a FMEA" (7 pages) and a 10-page FMEA form with a practical example.
Are you interested in this SOP and the associated form? The documents are mainly in German language. Yet, as a delegate of the ECA Course "GMP for Medical Devices" from 1-2 October 2014 in Heidelberg, Germany, you will receive these sample documents in English as free add-ons.