New medical devices regulations: A Call to Action for Medical Device Companies

New medical devices regulations: A Call to Action for Medical Device Companies
Whether your company produces medical devices or medical SW, 2019 is a pivotal year for you. The new EU MDR in May 2020, will change the landscape for all manufacturers by adding new requirements and changing classifications of many existing products.

Have you prepared your business for the new medical device requirements?

The Medical Devices Regulations (MDR) brings new requirements for companies that develop and sell medical devices. New documentation must be created, procedures must be adjusted, and many products will change classifications.

To continue selling your products on the European market, these requirements must be met – in many cases before May 2020!

But how exactly do you best prepare your business? What specific requirements apply to your company and your products? Will your product change classification?

To answer that, we have invited Zahra Hashemiyan and Kim Rochat from Medidee Services Scandinavia for an afternoon of discussion.

Program:

  • General requirements, changes and clinical evaluation by Zahra Hashemiyan
  • Requirements for developing and classifying medical software by Kim Rochat
  • Q&A: How the MDR will impact you and what you can do to prepare your company.
  • All participant will get a voucher of a free 1-hour consultancy session with the Medidee experts! (The topic is you to choose)

There will be a refreshment break between the talks.
Please notice: This event is not just for medical device companies. Everyone who is curious or Whether you are a Startup and you would like to know more about the MDR is welcome to attend.

Medidee is the leading European medical and in-vitro diagnostics devices consultancy firm, headquartered in Switzerland. With sites represented in Germany, Denmark, Belgium and USA Medidee is a global services supplier servings companies of all sizes ranging from academic startups to majors.

Information
  • When

    21. maj. 2019 16:30 - 18:30
  • Where

    EY Huset, Værkmestergade 25, 15. sal, 8000 Aarhus C

  • Registration Deadline

    18. maj. 2019 - 21:00

  • Organizer

    Kvindeudvalg, IDA Østjylland

  • Available Seats

    4

  • Event Number

    331373