More regulators worldwide are considering the benefits of flawed medical devices when deciding whether they should remain on the market. In response, the International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest revision of its voluntary risk management standard.
That standard, ISO 14971, instructs device-makers on how to best put together a risk management program; it was originally released in 2000 and underwent its first revision seven years later....
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?