Know-how webinar on regulatory affairs: Basic principles medical devices – part 2

Do you have an idea for a medical device? Find out what it takes to bring it to the market and what you need to do when. Sign up to learn about the basic principles of the early developing phases of a medical device in a regulatory perspective.

Part of the webinar series Know-how webinars on regulatory affairs:
Basic principles medical devices

  • 18 March 10–11 AM – part 1: 
    Defining and planning key steps
  • 25 March 10–11 AM – part 2: 
    The paperwork and requirements for documentation

Academic employees can access the recordings of the webinars by logging on to our webinar material webpage with their FEIDE user.

The webinars will take you through the basics of regulations and quality requirements when you are developing a medical device, and tell you what you need to get started. 

You will learn about:

  • Defining the product properly
  • ­Identifying the regulations and standards you need to comply with
  • ­The roles of the various bodies you need to involve
  • The key steps in a medical device development project
  • ­We will answer some general questions from the participants at the end of the webinar, but questions that are specific for individual projects, will be answered to the participants individually after the event.

Read the news article about why the centre has developed the webinar series.


25 March – part 2:
The paperwork and requirements for documentation

Topics

  • Documenting your device: Design and production requirements
  • Specification, verification and validation
  • Documenting and managing Risks
  • Documenting benefits – The clinical evaluation

Programme

  • 10:00–10:05: Welcome
    Beate Rygg Johnsen, senior adviser for innovation and industry collaboration, the Centre for Digital Life Norway
  • 10:05–10:45: The paperwork and requirements for documentation
    Tore Gjørsvik, Link Medical Research
  • 10:45–11:00: Questions relevant to all

18 March – part 1:
Defining and planning key steps

Topics  

  • Product categories: Rules and regulations overview 
  • Defining your product: The target product profile
  • Intended use, claims and markets
  • The quality management system and why you need one

Programme

  • 10:00–10:05: Welcome
    Beate Rygg Johnsen, senior adviser for innovation and industry collaboration, the Centre for Digital Life Norway 
  • 10:05–10:45: Defining and planning key steps
    Tore Gjørsvik, Link Medical Research
  • 10:45–11:00: Questions relevant to all

About the speaker Tore Gjørsvik

Tore GjørsvikProject director, medical device, LINK Medical Research

Tore has been working in research and development for the pharma and device industry for more than 20 years. He has experience from big failures and big successes, and learnt from them all. Now he works as a consultant for the pharma, med-tech and contract research organisation (CRO) industry with a focus to find effective technological and regulatory pathways for success. Tore has been leading teams across cultural and geographical borders, working hands-on from the research lab through prototyping, clinical development and commercialisation of medical devices. 

Published Jan. 26, 2021 4:28 PM - Last modified June 7, 2021 10:14 AM