ISO 13485:2016 - Fundamentals - Medical Devices - QMS - Requirements for Regulatory Purposes
What you'll gain from this course
This instructor-led course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses.
Tutor
This training will be delivered by one of our experts – click here to learn more .
Learning Outcomes
At the end of this training, learners will be able to:
- Identify key documents to help you understand ISO 13485:2016
- Recognize the primary elements of ISO 13485:2016
- Identify terms and definitions relative to the application of ISO 13485:2016
- Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
- Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios
Who Should Attend
This course is vital for any medical device professional, including regulatory and quality directors, managers, engineers, and auditors, who is responsible for implementing or working within a quality management system in accordance with ISO 13485:2016. This is a global standard, so it is applicable to devices intended for the market in any jurisdiction around the world.
510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market
AI Act, MDR/IVDR, QMSR: Practical AI compliance trainings for medical devices
AI in Medical Devices - Expectations in a Maturing Field
Biological Evaluation of Medical Devices - How to Succeed in Your Notified Body Assessment
CAPA Considerations: A Comprehensive Overview
Need help choosing?
Our training advisors can help you find the perfect match.