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Introduction to Regulatory Affairs for Medical Device Startups

Join us for an introduction to the regulatory world of medical device development and connect with fellow students, healthcare professionals and early stage startups.


26-09-2019 16:00 - 20:00


Nørre Allé 41, In the Gate (Right across from Panum)
2200 - Copenhagen


When developing equipment or software that can be used to prevent, diagnose, alleviate or treat illnesses, disabilities and injuries, proper approvals and quality assurance must be ensured. This evening, we have two important objectives:

  1. Getting insights into the world of regulatory affairs for you with an idea or an early stage startup within medical devices, and…
  2. Meeting other fellow innovators with interest or currently working with regulatory affairs and share experiences and ideas. Could be getting QA-procedures in place, writing your application to the Danish Medicines Agency.

The insights will be presented by two SUND Hub domain experts:

Claus Rømer
CEO, Owner and Technical Advisor drawing on +10 years of solid experience with development, test, technical documentation, approval and launch of products. He can help bring novel products and services to the market and transform the complexities of the regulatory landscape to simple plans and ensure efficient execution. Read more at

Kenn Milton

Senior Executive, with experience in the provision of IT and QA solutions whom for several years has been developing a SaaS solution based on the Quality Management experience carried by a strong wish to help all companies with Quality Management. Read more at

Meet the startups:
Furthermore, you will get the stories from our two SUND Hub Startups NoviPel and Vulcur Medtech. Both with a very present experiences and needs within the regulatory field.

Read more at and

The evening ends in good company with a free dinner.

Please download the description and programme below.



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