Risk management is an important aspect in the development of medical devices. Patients are already in a vulnerable position and, during diagnosis and treatment, they should be protected from risks that could further impact their health.
Download this free white paper for a discussion of:
- The development of risk management over the past centuries
- The risk management process as described in ISO 14971, including a discussion of the main changes in the third edition, which is expected to be published in 2019
- The broader context of ISO 14971 and its use in conjunction with other international standards to demonstrate compliance with regulatory requirements