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The next MedTech Regulatory Special Interest Group (SIG), hosted by regulatory affairs expert Richard Young, from AcclaimBiomedical Consulting Ltd, will provide a review of regulatory requirements and the application of biocompatibility in the new environment.
Richard will be joined by Philip Clay, Director and Principal Toxicologist, Chorley Consulting and they will be covering:
– Requirements of Annex 1 of the regulation 2017/745
– A regulatory perspective on existing products
– ISO 10993 the 2018 issue
– Biological Evaluation Plans
– Biological Evaluation reports
– What Are the interpretations of the requirements being taken by notified bodies?
– Application and assessment of Biocompatibility for existing products?
– What are the typical implications for Biocompatibility Rationale and testing?
– What are the practical constraints?
– Limitations of existing testing?
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.
Philip Clay, Director and Principal Toxicologist, Chorley Consulting
Philip is a UK and European registered toxicologist and specialises in safety assessment with over 30 years experience. He has published and presented widely in his expert field of genetic toxicology and also in the wider area of safety assessment. Chorley Consulting designs safety assessment programmes for medical devices and also provides toxicological advice for a range of product types. Philip is presently a BSI committee member for CH/194 (Biological evaluation of medical devices).
Chorley Consulting works with a number clients ranging from multinational manufacturers to single product start-ups. They have experience with assessing the biological safety of a wide range of devices including cosmetic surgery products, surgical implants, anaesthetic gas devices, catheters and invasive patient monitoring systems as well consumer healthcare products ranging from Class 3 devices down to Class 1. Their biological safety assessments have formed part of technical file submissions to a number of notified bodies without comment as well as supporting clinical trial applications. They also have experience with medical device submissions to regulatory authorities around the world including US FDA and China NMPA.
