ISO 13485 Medical Devices Foundation

ISO 13485 Medical Devices Foundation Course (1 day)

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 recognise the key clauses. You’ll find ways to increase efficiency, save costs and develop safe and effective medical devices. 

Course Duration: 1 Day
Delivery Method: Online

What will I learn?

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.

FAQs

    • 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

    • What will you learn?

    • Senior Management

    • Quality Managers

    • Regulatory Affairs Managers

    • Internal and external Auditors

    • Consultants