Introduction to Regulatory Affairs for Medical Device Startups

Join us for an evening of “inflight” into the regulatory world of medical device development and connect fellow students, healthcare professionals and early stage startups.

Insight

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 http://roemerconsulting.dk/

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 https://www.mybluelabel.com/

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 www.novipel.com and www.vulcurmedtech.com.

This evening will finish with dinner and networking.

Tilmelding: https://sundhub.typeform.com/to/ytuWQq

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Program

 

16:00 - 16:15 Velkommen og introduktion til SUND Hub
16:15 - 16:35 Introduktion til det sundhedsregulatoriske område for startups v. Claus Rømer , Roemerconsulting.dk
16:35 - 16:55 Introduktion til Quality Assurance og QMS Software v. Kenn Milton, Founder & CEO, MyBlueLable.com
16:55 - 17:10 Pause
17:10 - 17:20 Entrepreneurs' story: VulCur MedTech w. Julie Kaae Høgh, Quality Assurance and Regulatory Affairs Manager, VulCur MedTech
17:20 - 17:30 Entrepreneurs' story: NoviPel w. Alexander Hennings, CEO & Founder, NoviPel
17:30 - 18:00 Question and Answers + Discussion: How can the we help each other in the ecosystem of early stage medtech startups?
18:00 - 20:00 Dinner and Networking

We designed this event for …

  1. Students
    … Who would like to know more about, or perhaps want to take an active part in, the development of new innovation or start your own business within the healthcare sector. Come if you want to increase your knowledge and build a network across faculties, universities, schools and within healthcare professionals.
  1. Entrepreneurs
    … Working with solutions in the healthcare field.
  1. Health professionals
    … Who want to gain insight and inspiration from innovative ideas that currently are in development within students from the Faculty of Health and Medical Sciences as well as the ecosystem around the SUND Hub Incubator.