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The New EU Medical Device & IVD Regulations: Strategy & Requirements Workshop

December 12 @ 10:30 am - 4:00 pm

Venue

Hempsons
100 Wood Street, London, EC2V 7AN United Kingdom
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Organiser

SEHTA
Email:
Website:
https://sehta.co.uk
12
December

SEHTA, Psephos Biomedica & Mosaic Surgical would like to invite you to attend our EU Medical Device & IVD Regulations – Strategy & Requirements Workshop on Wednesday 12th December in London.

Why attend
The new EU Medical Device Regulation (MDR) is in its implementation phase and will be effective from May 2020.  All medical devices will need to comply with this new legislation.  Similarly, the IVD Regulation (IVDR) will be in force from May 2022.  Many companies are not yet ready for the journey let alone have a roadmap of how to get to compliance.

This one-day event will:-

  • Provide you with an overview of the key areas likely to need upgrading to comply with the MDR/IVDR
  • Assist you in assessing your company’s current preparedness for the transition
  • Give you a clear, practical guide to the next steps that you and your company need to take to gain CE Marking under the MDR/IVDR

Outcomes

  • Gain an overview of the new EU Medical Device and IVD Regulations
  • Understand the key areas of compliance required
  • Understand the technical documentation that should be in place for each device
  • Gain a plan of action for implementation and CE Marking under the new legislation

 

Costs to attend – You will be invoiced via SEHTA via PayPal

SEHTA Members – £199 + VAT per delegate

SEHTA non-members – £225 + VAT per delegate (it’s free to join SEHTA – Please click here)

The organisers reserve the right to decline registrations based on review. All applicants will be notified by email if they have been accepted for a place no later than Monday 10th December.

 

REGISTER YOUR INTEREST 

 

Agenda

10:30 – 10:45  Registration & Refreshments
10:45 – 10:55  Welcome, Jacques Du Preez, MD, Mosaic Surgical & Neil Roberts, COO, SEHTA
10:55 – 11:35  MDR/IVDR Overview & Q&A, Robin Stephens, CEO, Psephos Biomedica
11:35 – 12:15  Technical Documentation & Q&A, Jacques Du Preez, MD, Mosaic Surgical
12:15 – 13:00  Networking Lunch Break
13:00 – 13:40  Post-Market Activities (Inc PSUR) Q&A, Robin Stephens, CEO, Psephos Biomedica
13:40 – 14:10  EUDAMed and UDI & Q&A, Jacques Du Preez, MD, Mosaic Surgical
14:10 – 14:40  Clinical Evidence & Q&A, Robin Stephens, CEO, Psephos Biomedica
14:40 – 15:00  Refreshment Break
15:00 – 16:00  Roundtable discussion on Implementation Strategies (inc Q&A)