The next MedTech Regulatory Special Interest Group (SIG), hosted by regulatory affairs expert Richard Young, from AcclaimBiomedical Consulting Ltd, will cover the importance of the inclusion of the usability engineering process as part of the development and maintenance of medical products, which right now has never been more important.

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

Plus there will be time for the audience to ask questions.

TO BOOK YOUR FREE PLACE, CLICK HERE

This free-to-attend event is held as part of the ACTIS programme – a project part-funded by the European Regional Development Fund, click here to be re-directed to further information about the project. This event is classed as State Aid to participating businesses, the value of which is £190, but is delivered completely free of charge to participants.

Please note: whilst this event is held as part of the ACTIS programme, attendance is not restricted to companies in the SEMLEP area and is open to all.

DURATION: 1 hour and 30 minutes

Speaker Profiles: 

Richard Young, Managing Director, AcclaimBiomedical Consulting Ltd
Richard has an extensive background in regulatory affairs in addition to GMP (quality assurance), GLP (laboratory testing), and GCP (clinical). Spanning over two decades, these core skill areas have been developed with experience in products ranging from class 3 devices such as Orthopaedic implants (IIb) neurological robots, through electromedical devices such as infusion systems and cardio vascular products.

Richard brings a blend of pragmatism and experience to these disciplines that facilitates insightful problem solving approaches as well as solid solutions.

Richard’s skills and experience includes such areas as the development and implementation of effective quality management systems, auditing to ISO and FDA QSIT standards, and operating at national and international level through industry associations including Eucomed, ABHI and ABHI Technical Policy Group.

Greg Thay, Managing Director and Human Factors Consultant, THAY Medical – profile to follow