Regulatory Awareness Workshop (RAW) focuses on the medical device regulatory landscape that arises to startups and SMEs in the digital health sector. The RAW helps developers of medical and health-related apps and software to understand the importance of considering the medical device regulatory framework in the digital health sector.

What we offer

By using case studies, the following issues are explained:

  • When medical software falls under the medical device directive
  • How to classify medical device software
  • Which key regulatory standards are mandatory
  • The impact of the new regulation (MDR) on medical device software

Furthermore, the impact of the General Data Protection Regulation (GDPR) for medical software and mHealth apps will be discussed:

  • What is going to change and how is this affecting start-ups?
  • What are the first steps start-ups need to take to become compliant with the new rules?

The workshop will take 2,5 hours, incl. a presentation (1 hour) and a Q&A section (1,5 hours).

Why participate

  • Get an overview of the regulatory framework for software medical products and why regulatory compliance is important
  • Identify your own regulatory challenges
  • Develop ideas on how to tackle your regulatory challenges and get to know what support you can receive
  • Interact with other companies to discuss best practices and collaboration possibilities

 

Who can participate in the workshop:

  • Startups and SMEs – max 250 employees and no more than 50 millions in annual revenues.
  • Headquarters  must be  in Europe. Having a branch in Europe doesn’t work.
  • Investors in the field of digital health.
  • Other regulatory experts in the field of digital health.

 

Agenda

14:30 Introduction to eHealth Hub project

14:35 Regulatory challenges for digital health companies by using case studies:

  • When medical software falls under the medical device directive
  • How to classify medical device software
  • Which key regulatory standards are mandatory
  • The impact of the new regulation (MDR) on medical device software
  • Impact of the General Data Protection Regulation (GDPR) for medical software and mHealth apps

15:35 – 17:00 Questions and Answers, open discussion.

Speakers

I am founding Partner in Decalex Legal Solutions and currently I’m leading the Privacy & Data Protection department in my company.

My goal is helping my clients reach their business objectives by creating privacy safe environment for their companies to grow.

I have graduated Law and have a Master degree in E.U. Law. With more than 8 years experience in legal advising, I’m data protection passionate, and I am presently involved in developing and implementing GDPR strategies and privacy programs for my clients. I’m passionate about technology, so data protection came naturally for me. I’v been researching and working in this area for the last 5 years, long before it became cool. I offer support for companies in regards to privacy and data protection legislation, including GDPR.

One of my greatest achievements is working close to one of the biggest cloud storage supplier in the word, to implement national regulations in the field of Personal Data Cryptography. I also work with other international homologs to whom I provide help and support regarding national aspects on data protection legislation. Recently, I found that I really enjoy working with ehealth startups and all the medical data that comes with this field. If you want to discuss about privacy programs for you company, or specific topics la GDPR feel free to contact me.

The workshop is free, but registration is mandatory.

Contact details

If you have any questions please email Nicole Häusler  (N.Haeusler@engage-ventures.com) or Björn Hackbarth (b.hackbarth@engage-ventures.com)

Other details

This workshop is free of charge and it’s funded under the European Commission H2020 project,  eHealthHub.

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