SEHTA, Psephos Biomedica & Mosaic Surgical would like to invite you to attend our EU Medical Device & IVD Regulations – Strategy & Requirements Workshop.

Date: Wednesday 12 December 2018

Venue: Hempsons, 100 Wood Street, London EC2V 7AN

Times: 10:30 – 16:00

Cost: SEHTA Members £199 + VAT / Non-Members £225 + VAT per delegate.  You will be invoiced by SEHTA via PayPal after you have registered.

(it’s free to join SEHTA – just click here)

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

REGISTER YOUR INTEREST 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.

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)