An essential course tailored for medical device Regulatory Affairs (RA) and Quality Assurance (QA) professionals! This program serves as an introduction to the Quality Management System (QMS) criteria for medical devices. Whether you're a newcomer to the industry or a seasoned practitioner seeking to update your expertise, this course offers a comprehensive overview of QMS requirements outlined in the US FDA Quality System Regulation (QSR) 21 CFR 820 and the ISO 13485:2016 standard. Gain insights into the alignment of QSR and ISO 13485, explore methods to streamline processes, and discover opportunities for enhancing performance beyond the basic prerequisites.
Overview
Medical Device QMS Training Class
Class Content
In-Depth
Class Duration
Full-Day
Teaching Format
Live, Instructor-Led
Delivery Options
Virtual
Certification of Completion
Yes
Attendee Profile
This course is essential for individuals employed in the medical device sector, spanning from medical device manufacturers to their suppliers. It is highly recommended for professionals involved in various aspects of medical device development, manufacturing, and post-production, particularly those in quality control, regulatory affairs, technical, production, and management positions.
Engineering Managers
RA/QA Managers
Research & Development
Compliance and Legal
Executives New to Devices
