Course description
This BSI ISO 13485 training is a one-days 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.
Upcoming start dates
Suitability - Who should attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Consultants
- Anyone involved with the implementation of the standard
Outcome / Qualification etc.
- 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
Training Course Content
On completion of this training, participants will be able to:
- Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- Understand the relationship between ISO 13485:2016 and European Medical Device Directives
- Use ISO 13485:2016 as the basis of regulatory requirements worldwide.
Course delivery details
- You will gain 8 CPD points on completing the course
- Training course notes
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BSI, the British Standards Institution, is one of the world’s leading providers of training, certification, standards, regulatory approval, business improvement and management development for local and global audiences.
Our expert teams provide top quality training to organizations of all sizes and every type of industry - ranging from leading multinationals to small, innovative start-ups and from governments to charities. From understanding how a standard can help your business,...