Risk management under Regulation (EU) 2017/745, ISO 14971 and ISO/TR 24971 places clear expectations on manufacturers to ensure the right people, with the right qualifications, are responsible for the right activities.
The Risk Management Team template gives manufacturers a documented structure that covers designated roles and responsibilities, required qualifications, skills, and experience, alongside training and awareness requirements for each team member involved in risk management. Lifecycle stages at which each role is engaged are clearly defined, along with the frequency of data collection and review activities.
By formalising the team structure in this way, the organisation can demonstrate to Notified Bodies that risk management activities are carried out by competent, adequately trained individuals throughout the device lifecycle.
Structured by expert regulatory professionals, this template gives manufacturers clarity on one of the most overlooked yet critical foundations of a compliant risk management process.
Price: $50
