Legal Manufacturers of In Vitro Diagnostic products need to be aware of the scope and implications of the new European In Vitro Diagnostics Regulations 2017/746. Organisations must be realistic and prepared. Not only for the impact of changes in the short-term, but for the long-term implications to the development and maintenance of diagnostic products in the European Market. We only have until May 2022 to complete this compliance journey for some products, so it is strategically critical that all impacted businesses have fully understood and assessed the impacts on their business.
Medilink WM, in conjunction with Acclaim Biomedical Consulting Ltd. is offering a one day workshop to focus on the implementation of European In Vitro Diagnostics Regulations. This will provide attendees with detailed understanding of strategic impacts and possible solutions which may be used to ensure compliance going forwards.
Why attend?
By attending this workshop you will:
Gain a thorough understanding of the changes and strategic consideration of the major impact areas of the revised regulations with indepth review of the major clauses of the regulation.
Have the confidence and knowledge to review your own business and formulate plans to meet the transition to the IVDR based on this one day event
Gain insight and tools to plan and implement into your business strategy for continued access to the European market, by the deadlines set in the new regulations
Learn from other like minded business leaders, on their challenges and strategies to achieve the necessary legal process.
Meet the expert:
Managing Director Richard Young 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.
Target audience
Designed for business leaders with executive responsibilities as well as Quality Assurance and Regulatory Professionals.
This course quickly identifies the areas of strategic impact, possible costs and the time lines associated with the new EU In Vitro Diagnostic Device Regulations.
Booking information:
Delegate Fee:
Early bird fee – Register your place before Friday 23 August and receive a 10% discount
Member fee: £180+VAT
Non-Member fee: £215+VAT
To secure your place please contact Zoe Heather at zoeh@medilinkwm.co.uk or call 0121 452 5630
Invoices will be sent once booking has been confirmed by Medilink WM.