WEBINAR: The UKCA Mark (implications on medical devices and product import/export)
14th January 2021 @ 1:45 pm - 2:45 pm
The UK has left the EU and part of that transition is the establishment of a UK based alternative to the European CE mark.
In this Medilink Midlands webinar, regulatory affairs expert Richard Young will explore the requirements for the UKCA mark, the time frames associated with this transition, and the strategic considerations organisations should be planning for if they wish to maintain access to the UK market going forwards.
The session is intended for business, Quality, and Regulatory leaders and will feature 40 minutes of presentation followed by a 20 minute Q&A session.
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.