Course Aim: Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.
Course Description: This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.
How will you benefit?
This course will help you:
- Take the first steps towards ISO 13485:2016 certification
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees through CPD
- 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.