risk management

IVDR & Risk Management

We all know that Risk Management is an important part of a medical device’s quality management system. It also plays an important role in establishing objective evidence for the conformity with the General Safety and Performance Requirements (GSPR) of the EU 2017/746 (IVDR) IVD Medical Device Regulation. When carrying out a risk assessment, the state-of-the-art …

ISO 14971 Risk Management Process

The ISO 14971 Risk Management standard defines principles for a risk management process of medical devices. The requirements given in this standard help manufacturers to comply with the main regulations. So, by implementing an ISO 14971 Risk Management Process you can have a big step in your EU MDR, IVDR or FDA certification route. The …