FDA QMSR and ISO 13485:
Harmonisation Guide
Prepare Your Life Sciences Organisation for Regulatory Changes
The FDA’s harmonisation of 21 CFR Part 820 with ISO 13485 marks a significant shift in medical device quality management. This comprehensive guide offers UK and EU life sciences manufacturers essential insights into the Quality Management System Regulation (QMSR) harmonisation process, its impact on current practices, and strategies for ensuring compliance. Stay ahead of the curve and streamline your quality management processes with our expert analysis and practical recommendations
Understand the key differences between 21 CFR Part 820 and ISO 13485, and how the harmonisation will affect your quality management system.
Discover practical steps to prepare your organisation for the transition, including documentation updates and risk management processes.
Learn about the potential challenges and opportunities presented by the FDA QMSR harmonisation, and how to leverage them for improved efficiency and global market access.
Download the guide
About MasterControl
MasterControl is a leading provider of cloud-based quality and compliance software for life sciences and regulated industries. Our solutions help organisations streamline processes, ensure compliance, and accelerate time to market. Trusted globally, MasterControl empowers companies to bring life-changing products to more people, faster, while maintaining the highest standards of quality and safety.