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Medical Device QMS Overview Training

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.


Medical Device QMS Training Class

Class Content


Class Duration


Teaching Format

Live, Instructor-Led

Delivery Options


Certification of Completion


Webinar Details

Office Skyscraper


April 29th, 2024 | All-Day Event


$599 Per Attendee

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

Instructor Overview

Patrick Gora

Clear Vision Consulting, Inc.
President and CEO

Prime Path MedtechTM Inc.
Mountain Range

Patrick brings more than 31 years in the medical device industry in the areas of quality management systems and regulatory affairs. His experience and leadership have been focused on quality system implementation and remediation, and regulatory compliance. In addition to his time at Oriel STAT A MATRIX as a contracted instructor, Patrick has helped over 60 companies understand and implement medical device quality systems to meet FDA and ISO requirements.

Doctor Teaching on Seminar
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