Devices specific skills

Substance based devices (DSS02)


Description
Purpose of training:
New classification process for substance-based products

- What is a substance-based product?
- How do we qualify a substance-based product?
- Risk classification (in case of a substance-based medical device)
- Example
- Regulatory pathway for substance-based devices
- Questions answered in a Regulatory pathway for a substance-based device
- How to quote such a project?
- Subject Matter Experts
Content
  • Basic Training
  • Presentation Substance-based devices
  • Recording Regulatory pathway of substance-based products
  • Recording 1h webinar Substance-based devices
  • Training content
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever