Understanding medical device regulations for healthcare technologies
Course Summary
Medical device companies have to overcome many challenges when bringing a new product to market. A key element is understanding the medical device regulations (MDR), which involves all stages of product development from design and manufacture, to quality and marketing. By complying with such regulations, manufacturers can be sure products meet the necessary certification and verification standards.
This four-day, online course is designed to support innovative companies who work in the design and manufacture of medical devices to gain a stronger understanding of the processes involved when developing new technologies in a healthcare setting.
This course has limited spaces available. Should you be unable to attend, please cancel your booking via Eventbrite to allow us to re-allocate your place.
Failure to cancel and or attend may result in you being removed from any future courses.
The course will provide an overview of the medical device regulatory affairs and how their integration fits with the management of healthcare technology and the processes involved in adopting the medical devices.
It is intended that this course will also provide companies and individuals with an understanding of how to liaise with the medical sector such that higher uptake of innovative medical devices can be achieved.
- Lectures 1-6 cover knowledge and practical skill development
- Lectures 7-12 deal with the application and systems integration of concepts
By taking part in this course, participants will:
- Gain an understanding of the regulatory affairs framework for medical devices and the management of healthcare technologies in an NHS/clinical setting
- Develop a working knowledge of the key elements in the medical device design cycle – device classification, risk assessment, validation, evaluation, and vigilance
- Gain knowledge of key Quality Management System elements relating to medical device design and development
- Develop the ability to navigate and use key standards, e.g. ISO 14971, ISO 13485, and IEC 60601
- Generate awareness of standards and their use in the development of novel medical devices
- Develop skills to enable key elements of medical device technical files to be created
- Leave with an understanding of the management of healthcare technologies in the NHS
The course is targeted at:
- people wanting a change in career and learn about medical regulations
- people delegated by their companies to upgrade their skills in this field
- newly appointed staff in companies manufacturing medical devices
This course is being delivered in partnership with Heriot-Watt University and will feature lectures and presentations from the following experts:
- Dr. Richard Scott, Director of Medical Physics & Bioengineering at University Hospitals Bristol & Weston NHS Foundation Trust
- Mr. Brett Cohen, Clinical Scientist – Medical Device Governance at University Hospitals Bristol & Weston NHS Foundation Trust
- Dr. Davide De Mola, Leader of the Trust Medical Device Safety Office, University Hospitals Bristol & Weston NHS Foundation Trust
- Ms. Lise Sproson, NHS Innovation Manager and PPI Lead at NIHR Devices for Dignity MedTech Co-operative
- Prof Vicki Stone, Professor of Toxicology at Heriot-Watt University
- Prof Marc Desmulliez, Manager of the Medical Device Manufacturing Centre (MDMC) at Heriot-Watt University
- Dr. Michael Crichton, Assistant Professor in Biomedical Engineering at Heriot-Watt University
- Dr. Ferry Melchels, Associate Professor in Biomaterials and Biofabrication at Heriot-Watt University
Dates & Venues
| Date | 15, 22, 29 June, and 7 July 2021 |
|---|---|
| Location | Online |
| Duration | 10.00 - 16.30 |
| Cost | Free |
In collaboration with
