If you don’t have a world-class Quality Management System, you may be falling behind. Your QMS can go beyond compliance as you work to enable a culture of True Quality. With QMS requirements changing, it’s important to understand how this will impact your business and product.
In this True Quality Summit Series, we’ll spend two days diving into the future of QMS requirements. Learn about upcoming deadlines, new changes, and what you can expect as you work towards a world-class QMS.
And this is just the beginning - stay tuned for more sessions being added soon!
• Ensure your QMS is compliant and meets the updated requirements in evolving areas like risk management, Computer Software Assurance (CSA), ISO 13485, and more
• Understand key deadlines, updates, and dealbreakers that are necessary for you to get (and keep) your devices on the market
• Learn how to move away from paper-based approaches and build a QMS that scales
• Think proactively about what new threats the medical device industry may have to address in the future
• Medical Device Executives & Leadership Teams
• Quality Professionals and Management
• Regulatory Affairs Professionals and Management
• Clinical Affairs Professionals and Management
• R&D Engineers and Management
Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
ISO 13485: What's Next?
Moving up to the State of the Art in Risk Management
eMDR Program and Process
Modernizing your QMS to keep up with the Modern Age of Requirements
QMS from a Regulatory Perspective
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
Common Misconceptions on Medical Device Risk & Design Controls