Certification and Regulatory Workshop at HealthHubVienna.

With this question Fredrik Debong, Co-Founder of mySugr opened our recent workshop. The answers: Because nobody else is doing it, it will be a sustainable competitive advantage for your Start-up and the process is manageable after all!

As a Start-up, if you aim for certification as a medical product – you’re in for a ride. Therefore:

  • Describe your vision– where do you see your product/service in 5-10 years? What kind of value will you deliver to patients, doctors and other key-players in healthcare
  • Be strategic – Lay out the roadmap. Which “functions” need to be certified starting now, which ones in a later stage. The process will take time – be sure this is aligned with your financing scenario
  • You are in the driving seat! You define the product and it’s use cases, you manage risk and quality and you have to pro-actively drive the certification process.

Further Experts on the panel: Hermann Hämmerle, Regulatory Affairs Manager at Marinomed and Max Bauer, Head of Quality Management at SCARLETRED.

The following day Martin Schmid or en.co.tec worked with the HealthHubVienna Start-ups on their individual challenges concerning Regulation and Certification.