Software as a Medical Device: How to Avoid Regulatory Business Risk
Software as a Medical Device (SaMD), AI, and cybersecurity are playing an increasingly important role in the next generation of medical innovations. At the same time, the rules surrounding medical software, AI and data security are becoming more complex. If you include these regulations too late in the development, you run the risk of delays, additional costs or obstacles in certification.
On March 12, Life Cooperative is organizing a Regulatory Affairs meeting in Groningen with one central question: how do you prevent regulatory risk from turning into business risk?
We share this event because it is particularly relevant for startups, scale-ups and established companies in the Northern Netherlands that work on medtech, digital health, software, AI or cybersecurity.
Why this matters
Regulations affect product development, your certification process, your planning and sometimes even investment decisions. Early insight into these risks helps you make better strategic choices.
During this afternoon, you'll get practical insights into:
- What regulatory risks look like in different phases of product development
- What EU MDR, AI legislation and cybersecurity mean in concrete terms
- How to identify and limit risks in time
- How other companies deal with validation and certification
Program
The afternoon combines international expertise with regional practical experience.
Company showcase: Evidencio
Tom Hueting (COO) shows how Evidencio supports clinical prediction algorithms and helps developers with SAMD validation and certification.
Keynote speaker: Malte Knowles Schmidt
Global Portfolio Manager Software, AI and Cybersecurity for Medical Devices at TÜV SÜD
He takes you through the different phases of product development, shows how regulatory risks affect business decisions, and shares practical ways to mitigate those risks.
The afternoon ends with a networking session: a great opportunity to meet other innovators from the Groningen medtech ecosystem.
For whom?
This event is interesting for startups, scale-ups, SMEs and established companies active in medical technology, digital health, software, AI and cybersecurity. Professionals in Regulatory Affairs, Quality, R&D and management positions also gain valuable insights from this.
Are you working on medical software or AI-driven healthcare applications? Then this is a session that helps you navigate the regulatory landscape with greater certainty.
Time: 14:30 — 17:00
Location: Innokite, Kadijk 4, Groningen
Software as a Medical Device (SaMD), AI, and cybersecurity are playing an increasingly important role in the next generation of medical innovations. At the same time, the rules surrounding medical software, AI and data security are becoming more complex. If you include these regulations too late in the development, you run the risk of delays, additional costs or obstacles in certification.
On March 12, Life Cooperative is organizing a Regulatory Affairs meeting in Groningen with one central question: how do you prevent regulatory risk from turning into business risk?
We share this event because it is particularly relevant for startups, scale-ups and established companies in the Northern Netherlands that work on medtech, digital health, software, AI or cybersecurity.
Why this matters
Regulations affect product development, your certification process, your planning and sometimes even investment decisions. Early insight into these risks helps you make better strategic choices.
During this afternoon, you'll get practical insights into:
- What regulatory risks look like in different phases of product development
- What EU MDR, AI legislation and cybersecurity mean in concrete terms
- How to identify and limit risks in time
- How other companies deal with validation and certification
Program
The afternoon combines international expertise with regional practical experience.
Company showcase: Evidencio
Tom Hueting (COO) shows how Evidencio supports clinical prediction algorithms and helps developers with SAMD validation and certification.
Keynote speaker: Malte Knowles Schmidt
Global Portfolio Manager Software, AI and Cybersecurity for Medical Devices at TÜV SÜD
He takes you through the different phases of product development, shows how regulatory risks affect business decisions, and shares practical ways to mitigate those risks.
The afternoon ends with a networking session: a great opportunity to meet other innovators from the Groningen medtech ecosystem.
For whom?
This event is interesting for startups, scale-ups, SMEs and established companies active in medical technology, digital health, software, AI and cybersecurity. Professionals in Regulatory Affairs, Quality, R&D and management positions also gain valuable insights from this.
Are you working on medical software or AI-driven healthcare applications? Then this is a session that helps you navigate the regulatory landscape with greater certainty.
Time: 14:30 — 17:00
Location: Innokite, Kadijk 4, Groningen