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
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Consultants and anyone involved with the implementation of the standard
On completion, you should gain the knowledge and skills to:
- Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- Identify the relationship between ISO 13485:2016 and European Medical Device Directives
- Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide
Prerequisites: There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.
- This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor. This will provide the delegate with the flexibility of attending it from the convenience of home or office, without travelling to BSI facility. A stable internet connection, headset with USB connection, a quiet and suitable work area. In advance of the training a ‘testing room’ will be provided for delegates to confirm their hardware works and that they can fully participate in the training.
- Examination will be conducted online via an e-assessment platform 'Questionmark'. Invigilation will be done through delegate’s webcam and microphone.
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.