Free

Lunch & Learn: How to gain CE Marking for Medical Device Start Ups

Event Information

Share this event

Date and Time

Location

Location

Health Foundry

1 Royal Street

London

SE1 7LL

United Kingdom

View Map

Event description

Description

Come and find out How to gain CE Marking, Richard Hall’s presentation will cover:

  • Global and local Regulations

  • What is CE Marking

  • Directives are moving to Regulations – the changes and their implications.

  • Product Classification

  • Fundamental techniques of Product Design and Development

  • Structure of a typical Technical File and what’s included

  • ISO 13485 – understanding the standard and how it relates to CE Marking


Richard Hall is an experienced QA professional with over 25 years’ experience of developing and manufacturing medical devices & IVD's in a range of companies, from start-up to blue chip international healthcare businesses. His last full-time position was Quality and Design Manager for Bio-Rad Laboratories in the UK which he held for 5 years before starting QMS Consultancy in 2014.

Richard now specialises in supporting medical device start-ups to gain ISO 13485 certification and to CE mark their devices. More recently he has extended his knowledge to help companies with MDSAP compliance

In 2016, Richard began to offer bespoke ‘Drop-In Systems’. By using proprietary software, he can create an ISO 13485 compliant QMS and a CE Technical File Template, specific to meet the client’s needs. These are generally created, installed and trained within 1 week and greatly simplify and accelerate the route to market for start-up businesses.

Richard offers a tailored approach with each client and can act as their in-house Head of Quality or provide training and the necessary tools and platforms for the company to manage their own Quality System.

Although based in the UK, his client base is located around the world, including the US, Singapore and New Zealand. Richard welcomes interest from firms outside the UK who require QA or Regulatory assistance in Europe or further afield

A highly motivated person, Richard enjoys the challenge of getting the job done well and continuously looks to improve both himself and the companies he interacts with.

Lunch will be provided.

Share with friends

Date and Time

Location

Health Foundry

1 Royal Street

London

SE1 7LL

United Kingdom

View Map

Save This Event

Event Saved