This Regulatory Awareness Workshop (RAW) specifically focuses on challenges facing European startups and SMEs in the development of digital health solutions.

By showing practical examples this workshop helps to understand:

  • when a software application becomes a medical device and  
  • how to classify software as a medical device under the current Medical Device Directive and the future Medical Device Regulation 

Additionally a brief overview of the key requirements will be provided for software developers falling under the new medical device regulation.  

The workshop is sponsored and hosted by our network partner CE plus GmbH, a regulatory service provider for medical devices.

 

Important dates

  • Recruitment ends: 28.05.2018 
  • Live session:  29.05.2018, Sitges (Health 2.0)

 

Duration 

  • Presentation: 60 minutes  
  • Q/A Session: 30 Minutes  

The speaker will be available for additional questions either directly after the workshop or at the CE plus booth (#740) in the Exhibition Hall. 

 

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 

 

Our target 

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 

*Only registered participants of the Health 2.0 Europe/HIMSS Europe conference can take part in the workshop.

 

Agenda   

  • Introduction to eHealth Hub project (10:00)
  • Regulatory challenges for digital health companies by showing practical examples (10:05): 
    • when a software application becomes a medical device 
    • how to classify software as a medical device under the current Medical Device Directive and the future Medical Device Regulation 
  • Questions and Answers, open discussion (11:00 – 11:30)

 

Speaker 

Oliver Hilgers is the Head of the Active Medical Devices Team at CE plus, a regulatory service provider located in Germany. Oliver is an expert for Medical Software/Apps according to the European Directive and looks back on a ten years experience in CE-marking Medical and also In Vitro Diagnostic Devices. Being a member of several committees for medical software development according to IEC 62304 helps him to discuss the latest trends and software practices and to transfer his experience to the clients. Oliver´s passion is to support software developers to make sure that innovative Medical Software reaches the patient´s computer or smartphone quickly and safely. Oliver Hilgers, Regulatory Affairs Manager

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 sponsored and hosted by our partner CE plus GmbH, a regulatory service provider for medical devices.

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