An intensive 2-day training course designed specifically for regulatory professionals, quality managers, and medical device manufacturers seeking to understand the recent harmonization between US FDA 21 CFR Part 820 and ISO 13485:2016. This course will provide a comprehensive overview of the key changes, practical implications, and strategic approaches to align your quality management system with the new requirements.

Participants will gain insights into the FDA’s Final Rule, explore thematic groupings of the 83 FDA comments and responses, and engage in interactive case studies to deepen their understanding. Through expert-led sessions and collaborative workshops, attendees will learn the critical steps to ensure compliance, enhance product quality, and streamline regulatory processes.

By the end of the course, you will be equipped with the knowledge and tools to navigate the complexities of the harmonized standards, ensuring your organization’s readiness for the evolving regulatory landscape.

Course Aim

This course aims to help you gain an understanding of how the US Food Drug Administration (FDA) is incorporating by reference the Quality Management System (QMS) requirements of ISO 13485 into 21 CFR Part 820.

How will I benefit?

This course will help you to:

• Recap on the requirements of the 21 CFR Part 820 and ISO13485:2016
• Understand why the US FDA is transitioning to an updated quality management system.
• Anticipate the potential benefits that can be derived from this transition.
• Grasp the fundamental concepts and organizational structure of FDA’s QMSR.
• Recognize the primary implications of implementing the QMSR.

What will I learn?

On completion of this course, you will be able to:

• Comprehend the significance of the new Quality Management System Regulation (QMSR) for device manufacturers.
• Familiarize yourself with the terminology and definitions associated with this field.
• Gain an understanding of how the FDA's Final Rule integrates ISO 13485:2016 with the existing 21 CFR Part 820 quality management system (QMS) to create the new QMS regulation (QMSR).
• Appreciate the impact of the QMSR on the medical device industry, considering both its opportunities and challenges.
• Apply your knowledge of the QMSR to effectively manage quality systems for medical device manufacturers in both the USA and the EU.
• Develop the skills necessary to prepare for the transition to the QMSR, including understanding key milestones and compliance expectations.

Who should attend?

Senior management, compliance officers, quality managers, quality assurance specialists, regulatory affairs managers, internal and external auditors, consultants, and anyone involved with implementing QMS standards.

Duration

2 days

How will I learn?

Our high impact accelerated learning methodology improves knowledge retention and skill development. This course is interactive and activity-based, resulting in a deeper understanding of the content and more effective application in the workplace.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

Attendees should have already attended BSI’s ISO 13485:2016 Requirements TPECS Course, or already have a working knowledge and understanding of the ISO 13485 standard. It will also be helpful to have read the FDA Final Rule released on February 2, 2024, before attending this course.

Further Information

Detailed course notes provided.

Related Training

You may also be interested in attending our ISO 13485:2016 Clause by Clause, Implementation, Internal Auditor, and Lead Auditor courses.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.