Medilink Midlands will be hosting a webinar focused on usability engineering for IVDR and MDR compliance.
The next MedTech Regulatory Special Interest Group (SIG), hosted by regulatory affairs expert Richard Young, from Acclaim Biomedical Consulting, will cover the importance of the inclusion of the usability engineering process as part of the development and maintenance of medical products.
As companies transition to compliance with the revised European Regulations, the importance of this process for the success of the design and conformity assessment activities of an organisation are critical.
Richard will be joined by Greg Thay, managing director and human factors consultant, THAY Medical and they will be covering:
- The regulatory requirement for Usability
- General Safety and Performance Requirements
- Integration with risk Management
- Usability Engineering IEC62366 as a process based standard in product design
- Documentation required
- Common pitfalls
There will also be time for the audience to ask questions.
For more information, click here.
