FREE WEBINAR

The Harmonization of Regulatory Guidance: QMSR and ISO 13485

The FDA finally released their much talked about proposed rule change for the Quality System Regulation to the Quality Management System Regulation in February of 2022. The rule aligns the FDA regulations more fully with ISO 13485, and will mean significant changes to 21 CFR 820. This webinar will discuss the history of the regulation, why it’s a big deal, and what your organization can do to be ready for the change.

In this webinar we will:

• Review the background and history of the QSR, and why they are making updates to the QMSR
• Describe the relationship to ISO 13485
• List key differences between the old and new regulations, and between ISO 13485
• Have actionable items to prepare for the changes now