The next MedTech Regulatory Special Interest Group (SIG), delivered by regulatory affairs expert Richard Young and GS1 standards professional Chris Florey, will explore the requirements for product traceability and Unique Identification for the EU and Global Use, immediate and future considerations for a business.
This webinar will cover:
Richard Young, AcclaimBiomedical Consulting Ltd:
– Regulatory background
– Eudamed
– MDCG guidance so far
Chris Florey, GS1 standards professional, GS1 UK:
– Basic UDI DI (GMN)
– UDI-DI and UDI-PI
– UDI for software as a medical device
– Human Readable Interpretation (HRI)
– Barcode verification
There will be time at the end of the presentations for a Q&A session. Please submit any questions in advance for Richard and Chris to discuss during the presentation on the online booking form.
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 £127, 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
TO BOOK YOUR FREE PLACE, CLICK HERE
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.
Chris Florey, GS1 standards professional, GS1 UK
Chris has over 15 years experience of working with organisations to adopt GS1 standards to meet trading partner and regulatory requirements, and his focus for the past eight years has been within the healthcare industry, assisting medical device and pharmaceutical manufacturers in implementing the NHS eProcurement strategy, the FDA UDI rules, the EU MDR and the FMD using GS1 standards. Whilst not a regulatory expert, he is able to share his experience of engaging with the regulators and thousands of manufacturers and distributors that are GS1 UK members.
