ISO 13485:2016 CFR 820 – Quality Management System Regulation (QMSR)

This enlightening webinar explores the harmonization of the Quality System Regulation (QSR) with the international standard for medical device quality management systems, ISO 13485:2016.

Key Topics:

• Understand the requirements for a robust Quality Management System (QMS) in the medical device industry.
• Learn how ISO 13485:2016 aligns with FDA regulations and ensures consistent compliance.
• Gain insights into risk management, design controls, and post-market surveillance.

Webinar presenter

Sean McMahon
Sean McMahon is an IT Professional with 30 years of experience helping customers with the digital transformation to the modern workplace. He began his career in 1994 helping organizations with Y2K compliance challenges. He helps solve business challenges with technology solutions and services. He believes the success of modern businesses is dependent on connectivity, ease of access to information, the speed of response, network of collaboration and the ability to make decisions in real-time. To remain competitive and desirable, organizations need to transform the employee work experience by promoting efficiency, innovation and growth as well as breaking down existing communication barriers. The key to success lies in an effective implementation of a digital transformation strategy capable of driving true organizational and cultural change and delivering business value. Sean has dedicated the past 12 years to helping companies with Cybersecurity challenges and initiatives..