What we offer
The 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.
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
The workshop will take 2 hours, incl. a presentation (1 hour) and a Q&A section (1 hour).
Why participate in the regulatory awareness workshop
- 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 is 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
When?
16th November 2017, 10:00 - 12:00, @ Frontiers Health in Berlin
Agenda
10:00 Introduction to eHealth Hub project
10:05 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
11:05- 12:00 Question and Answers, open discussion
Our expert
Prof. Dr. Christian Johner is the founder and owner of the Johner Institute for Healthcare IT. He is passionate about software development, medicine, quality management and teaching. Together with his team, he consults countless medical technology manufacturers in Europe and in the USA in their medical software development and authorization. Christian Johner is a part of IEC 62366 standards committee as one of the pioneers in his field. His articles have about 1000 daily readers.
As a professor, Christian Johner teaches software architecture, software engineering, software quality control in Constance university of applied science. He has taught and partly still teaches in Krems university, St. Gallen university and Würzburg university. Dr. Johner is a well respected speaker for medical products software engineering, usability engineering and medical IT.
Professor Johner is the head of institute for “Healthcare IT”, where specialists and executive managers complete professional seminars and extra-occupationally study (Master of Science and MBA). The students are recruited as employees from almost all well-known medical technology manufacturers and hospital chains.
Christian Johner is a postdoc in physics and has been working in healthcare field for over 25 years.
Contact details
If you have any questions please email Nicole Häusler ([email protected]) or Hackbarth Björn ([email protected])
Registration form
The workshop is free, but registration is mandatory.
REGISTER NOW!