Ensuring Regulatory Compliance by Design
Healthcare Regulations
In MedTech innovation, designing for safety and compliance is no longer optional — it’s a competitive advantage. This programme helps you understand how to integrate regulatory thinking into every step of product development, ensuring your technology is ready for market from day one.
Through real-world examples and case studies, you’ll learn how to design, test, and validate medical devices that meet European standards while fostering a culture of innovation and safety.
Applications to this programme are ongoing. Don’t miss this opportunity and enrol now!
What you get
COMPLIANCE BY DESIGN
Learn how to integrate regulatory and quality requirements early in your design process
RISK TO READINESS
Identify, assess, and mitigate risks to bring products to market faster and safer.
FROM IDEA TO MARKET
Build a clear roadmap from concept and testing to certification and launch.
FLEXIBILITY
Study at your own pace with an asyncronous online format designed to fit your schedule
HANDS-ON
Apply healthcare regulation concepts through real-world case studies
CERTIFICATION
Receive certification validating your Medtech Regulations skills and knowledge
EXPERT GUIDANCE
Learn directly from leading experts behind Europe’s most renowned institutions in Healthcare Regulations
CAREER PATHWAY
Build a strong foundation to progress into EIT Health Healthcare Regulations programmes
What you'll learn
Learning Outcomes
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- ✅ Integrate safety and compliance into early product design.
✅ Build documentation and strategies to support CE certification.
✅ Apply risk management and testing principles across the development cycle.
✅ Design and assess usability and clinical performance effectively.
✅ Plan for post-market monitoring and continuous improvement.
✅ Lead multidisciplinary teams through compliant innovation processes.
- ✅ Integrate safety and compliance into early product design.
Curriculum
Eligibility Requirements
Ideal for professionals and postgraduate learners in MedTech, biotechnology, and digital health who want to strengthen their ability to lead compliant innovation.
Speakers
Giandomenico Nollo
UNITN
Francesco Tessarolo
UNITN
Michela Masè
UNITN
Alessio Bucciarelli
UNITN
Alice Ravizza
INSIDE AI
Noemi Conditi
INSIDE AI
Florinda Coro
INSIDE AI
Paolo Pescio
EUROFINS
Anja Friedrich
EUROFINS
Partners
Department of Industrial Engineering - University of Trento
Inside AI
