This BSI ISO 13485 training is a one-day course for medical device manufacturers. It shows how to use ISO 13485:2016 as the basis for a quality management system (QMS). It also explores the interaction between ISO 9001:2015, the European Medical Device Directive and the US FDA's Quality System Regulation.
From consultants to senior managers, this course is suitable for anyone who needs to implement the standard. You’ll learn to use ISO 13485:2016 as the basis for regulatory requirements worldwide and recognize the key clauses.
Choose to take the BSI ISO 13485 training course either in the classroom, live online or on-demand with self-paced eLearning. You’ll find ways to increase efficiency, save costs and develop safe and effective medical devices.
How will I benefit?
- Understand how to meet regulatory requirements to increase patient safety
- Monitor supply chains for continuous improvement
- Take the first steps on your learning journey to ISO 13485:2016 certification
- Gain an internationally recognized BSI training certificate
- Senior management and those tasked with implementing ISO 13485
- Quality managers and regulatory affairs managers
- Internal and external auditors
- Anyone involved with the implementation of the ISO 13485:2016 standard
- Understand the scope and use of ISO 13485:2016 as basis of Medical Device Regulations
- Interpret the clauses of ISO 13485:2016 worldwide
- Differentiate between ISO 13485:2016 and ISO 9001:2015
- Define ISO 13485:2016 management roles and responsibilities
- Compare requirements between ISO 13485:2016 and the FDA’s Quality System Regulation
This training course is HRD Corp claimable programme. On completion, you will be awarded an internationally recognized BSI Training Academy certificate.