regulatory compliance made easy


Risk management ISO 14971

Are you looking to CE mark your medical software? Or are you working in medical software in general? We offer a workshop in risk management specifically designed for medical software.

By attending this workshop you will get the tools and the practical guidance to conduct your own risk analysis in accordance with ISO 14971. You will learn about what risk management is, how to understand it in a medical software context, and why it is important for your product and company.

Content of the workshop

  • Theory on risk management according to ISO 14971
  • Fika break
  • Conducting a risk analysis in small teams on a specifically designed medical software case
  • Discussion about the case
  • Wrap up and certificate

We firmly believe that achieving regulatory compliance does not have to be difficult, and we will show you how to in this workshop.

Location and time
To be announced!

H2 Health Hub
Hälsingegatan 45, 113 31 Stockholm, Sweden

Registration fee per attendee: 4500 SEK (excl. VAT).
If you join with 3 or more people from the same company, you will receive a 15% discount on the registration fee.

No previous knowledge or experience with risk management is needed for this workshop.

Please, fill in the form beside to sign up.
When you sign up, you agree to the registration fee mentioned above. The invoice will be sent one week prior to the course.

For any other questions regarding our workshop, do not hesitate to send us an email at

Your instructor

Karlijn van Herpen, project manager and regulatory affairs manager at Careful apps. Experienced bioentrepreneur from Karolinska Institute.