QA Regulatory Forum: The basics of all regulatory issues – your quality system

06 September
08:00 - 10:00

Oslo Science Park
Medical Growth House

Get the basics on quality management systems – the do’s and don’ts – and meet the experts. This is essential for all medical device development!

The most important for medical devices on the regulatory side is to have your quality management system in order, and there are so many issues to consider. We are very lucky to have Greer Deal from GRS (Global Regulatory Services) from the UK here and she will give you an introduction as well as a good overview of what the issues entails. She will address ISO 13485:2016 with focus on:

    • What is involved in setting up a QMS system?
    • Timeline for certification according to ISO 13485:2016

We will also get the practice presented by a case from our partner LINK Medical.

Agenda:

08:00 – Mingling and light breakfast

08:30 – Welcome to Aleap and Norway Health Tech by Erling Nordby (Managing partner Aleap)

08:40 – QMS Systems by Greer Deal

09:25 – Your QMS has been implemented/certified. Now what? “Finally! Let’s go back to do some real work and forget about that QMS for a while.”  That’s not how this really works. This is the time you actually start to work with and improve your QMS in daily life.- Brief introduction to some of the processes with examples on how to work with and monitor your QMS. By Helen Therese Kalfjøs (Senior medical device manager) LINK Medical .

09:45 – Q&A session

10:00 – Wrap up

If you would like arrange a 1:1 meeting with Greer, she is available for that after the meeting and the following day (Sept 7th). Send an e-mail to us to book time (remember to indicate when is best for you, although we cannot guarantee the time)

We hope to see you here – WELCOME!

Register

Speakers

Greer Deal

Director - GRS - Global Regulatory Services

greer@globalregulatoryservices.com

Hèlen Therese Kalfjøs

Senior Medical Device manager - LINK Medical

helen@linkmedical.no