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Impact & Assessment of European Medical Device Regulations


17 September 2019
09:30-16:30

Are you ready for the imminent new medical devices regulations applicable from May 2020?. Implementation of the new regulations needs to be a priority for industry. In less than 10 months, medical device regulations are set to change. With such a short timeline, organisations need to act now to ensure minimal disruption to their organisation and its supply chain.

Medilink WM, in conjunction with Acclaim Biomedical Consulting Ltd. is offering a one day workshop to explore the new European regulations for medical devices including;

  • The impact the regulations will have on SMEs, in regards to costs
  • An overview of the remaining short timeline
  • Notified Bodies  – impact on SMEs, and how to overcome potential barriers
  • The changes to CE Marking 

Why attend?

By attending this workshop you will:

  • Gain a stronger understanding of the new EU regulation structure and its impact to industry, with a clear practical 'next steps' guide.
  • Formulate a strategic approach – the immediate actions you need to consider to comply and how to move forward in this new environment

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.

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.

Detail

Date:
17 September 2019

Time:
09:30-16:30

Organiser

Medilink West Midlands Phone:
0121 452 5630 Website:
http://www.medilinkwm.co.uk

Venue

Medical Technologies Innovation Centre
4 Greenfield Crescent
Edgbaston
Birmingham
B15 3BE


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