Introduction to Medical Devices - Day One

Wednesday 7 th June 2017

10.15-10.45

Registration

10.45

Introduction to TOPRA

Christopher Bailey TOPRA

Day 1 Welcome and Introduction

Jonathan Hughes JHRA

11.00

12.00

Lunch

13.00

Medical Device Classification & Drug Device Borderline

Theresa Jeary LRQA

Tea and coffee break

15.40 – 15.55

15.30-18.45

Case Study (Part 1)

Jonathan Hughes JHRA

19.00

Welcome Dinner in restaurant

Thursday 8 th June 2017

Jonathan Hughes JHRA

08.30

Day 1 Re-Cap & Day 2 Intro

08.45

Conformity Assessment & ISO 13485

Howard Dobbs Howard Dobbs Consulting Ltd

Tea and Coffee break

10.45

Crispin Bennett CromSource

11.00

Clinical Evaluation & PMCF

12.30

Lunch

13.30

Sue Spencer UL

In-Vitro Diagnostics

Coffee and Tea

15.00

Jonathan Hughes JHRA

15.15-18.00

Case Study (Part 2)

Dinner in restaurant

19.00

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