Browse by topic
Subscribe to our news

iso 14971

ISO 14971: 2019: 3 Key Changes from ISO 14971: 2007

As the underlying risk management process for medical devices, the ISO 14971 standard is a critical component of regulatory and quality compliance. When new versions are released and harmonized, it’s up to manufacturers to learn about the changes to update systems accordingly. However, there is often a gap between the time a new version is released and when regulatory organizations require compliance.
Read Now

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!