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Apr 19

SEHTA Event – Medical Device Clinical Strategy & Requirements Workshop – June 2018

Psephos event bannerSEHTA, Psephos Biomedica and Mosaic Surgical would like to invite you to attend our Medical Device Clinical Strategy & Requirements Workshop on 6th June in London.

 

Date: Wednesday 6th June

Venue: Hempsons, 40 Villiers Street, London WC2N 6NJ

Times: 11:00 – 15:10

FeeSEHTA Members – £125 + VAT per delegate / SEHTA non-members – £175+ VAT per delegate (it’s free to join SEHTA – www.sehta.co.uk/membership)

You will be invoiced via SEHTA via PayPal

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 28th May.

Why attend
Clinical strategy, evidence and evaluation are central to product approval and market access. It’s a requirement of the new EU Medical Device Regulation (MDR: article 61) that a medical device company have a regulatory strategy and of the MDR and MEDDEV 2.7/1 rev 4 that the company have a clinical evaluation strategy.
In order to generate sales, organisations need to have thought through the clinical elements for market access as this will put them back months, if not years, if not understood and completed when initially gathering clinical evidence.
Companies need to be prepared and have solutions in place to address this and their ongoing clinical requirements. Getting your clinical strategy wrong will delay approval and also access.
Outcomes
  • Understand clinical strategy and how that fits within an overall company strategy
  • Understand the role of clinical investigations, evaluations, evidence and post market clinical follow ups
  • Understand how clinical evidence and the role of clinical strategy enables market access
  • Interact with fellow practitioners and presenters during the Q&A

REGISTER YOUR INTEREST BUTTON

Places are limited so register today

 

Agenda

11:00 – 11:30 Registration

11:30 – 11:40 Welcome, Dr David Parry, CEO, SEHTA & Jacques du Preez, MD, Mosaic Surgical

11:40 – 12:20 Clinical Strategy & Q&A, Robin Stephens, CEO, Psephos Biomedica

12:20 – 13:00 Clinical Evaluation & Q&A, Dr Anna Guildford, Clinical Evaluation Specialist, Psephos Biomedica & Robin Stephens

13:00 – 13:40 Networking Lunch Break

13:40 – 14:20 Clinical Investigations & Q&A, Robin Stephens

14:20 – 15:00 Clinical Evidence for Market Access & Post Market & Q&A, Jacques du Preez & Neil Roberts, Medical Technology Advisor, SEHTA

15:00 – 15:10 Closing Remarks, Dr David Parry & Robin Stephens