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EU Medical Device Technical Files Workshop

March 20 @ 8:00 am - 5:00 pm

Venue

Hempsons, 100 Wood Street, London, EC2V 7AN
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Website:
https://www.sehta.co.uk/Post/mhealth-app-national-workshop

Organiser

SEHTA
Email:
Website:
https://sehta.co.uk
20
March

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 requirements for technical documentation in order to comply with the MDR and your conformity assessment
  • Assist you in assessing your company’s current preparedness for the transition
  • Provide a clear, practical guide to the next steps that you and your company need to take to meet Technical documentation requirements to gain CE Marking under the MDR

Outcomes

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

Target Companies: Medical Device companies and Pharma companies with combination products.

Target Market:  C-suite, executives, product owners, medical officers, regulatory and clinical specialists within a company that need to understand the overall requirements of the new Medical Device Regulation for their medical devices to enable them to place a device on the market and to maintain access after May 2020. All company sizes will find it useful, but particularly helpful for smaller, resource constrained organisations

Please note that places are limited & the organisers have the right to review all applications. Confirmation will be sent by 31st May and invoices will be sent separately by SEHTA.

Please note that in compliance with our GDPR policy, by registering for this event, you are automatically added to our mailing list.  If you wish to unsubscribe email info@sehta.co.uk with your details.

Agenda

Times Programme Speaker
10:30 – 10:45 Registration & Refreshments
10:45 – 10:55 Welcome Jacques Du Preez, MD, Mosiac Surgical & Director, Psephos Biomedica & Neil Roberts, COO, SEHTA
10:55 – 12:15 Introduction to Technical Files & Design History Files

  • CE Marking
  • Conformity Assessment
  • Overview of Regulations & Requirements
  • Role of Quality Management System
Robin Stephens, CEO, Psephos Biomedica&  Jacques Du Preez, MD, Mosaic Surgical & Director, Psephos Biomedica
12:15 – 13:00 Networking Lunch Break
13:00 – 13:40 MDR Annex II – Technical Documentation Jacques Du Preez, MD, Mosaic Surgical & Director, Psephos Biomedica
13:40 – 14:10 Annex I – General Safety & Performance Requirements Jacques Du Preez, MD, Mosaic Surgical & Director, Psephos Biomedica
14:10 – 14:40 Annex III – Technical Documentation on Post Market Survelliance Robin Stephens, CEO, Psephos Biomedica
14:40- 15:00 Refreshment Break
15:00 – 15:30 Clinical Evidence Introduction Robin Stephens, CEO, Psephos Biomedica
15:30- 16:00 Roundtable Discussion (inc Q&A) All

 

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