Introduction to ISO 13485:2016 Medical Devices

Level Understanding Duration 1 day

Available to book: Virtual instructor led training £795 + VAT View dates and book now

Available to book: On-demand elearning View details

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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 you 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

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.
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Consultants
- Anyone involved with the implementation of the standard
We are:
- A full scope Notified Body
- A full scope UK Approved Body
- A national Standards Body
- An accredited ISO 13485 Certification Body
- A recognized Auditing Organization under the Medical Device Single Audit Program
- A globally recognized Certification Body
- You will gain 8 CPD points on completing the course
- Training course notes

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