Risk management for medical devices and the new ISO 14971

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