The European Device Directives and Regulations, the US Device regulations and the China Device regulations require risk management as part of product development in the product dossier to authorize your products for distribution in their territories. A good risk analysis and evaluation is central to the development process and will be a valuable tool for troubleshooting and customer service.

The European Device Directives and Regulations and the US CFR device regulations don’t specify how to perform risk analysis. The regulators expect you to justify your risk management process. Following the harmonized ISO14971 risk management standard meets their expectations and complies with the regulatory requirements. The ISO14971 standard defines a risk management process and different risk analysis tools to use, such as fault tree analysis and failure mode effects analysis.

Developing a risk management file in a medical device or IVD company is not easy.  MARACA international can lead you stepwise through the risk management process with templates and guidance. This leads to a risk management file which is well-structured, consistent, transparent en compliant with the regulatory requirements.