Description
This basic course gives you an insight into regulatory requirements and processes for the successful development of medical devices and in-vitro diagnostics. What elements must be included in development projects to ensure that time and cost constraints are met and regulatory requirements are taken into account from the outset?
Seminar contents
Regulatory requirements
- EU regulations for medical devices and IVDs
- Global: The GHTF Regulatory Model
- USA: FDA – QSR: Design Controls
Processes for medical device development
- Project management
- Quality assurance in development
- Sub-processes for the development process
- From requirements management to design transfer
- Supporting development processes
- Where can I find support, useful resources and websites?
- Do’s and don’ts – unwritten laws
- Field reports: usability, process validation
Date
13.03.2026 from 9:00 to 16:30
Participants
This basic course is also suitable for participants with little or no previous knowledge. However, you will need experience with (medical) product development to take part in this seminar.
Your trainer
DI Martin Schmid, Managing Director & Senior Consultant at en.co.tec Schmid KG
Information about our trainers
Costs
- Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
- Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
- incl. seminar documents as PDF and confirmation of participation
- All seminar discounts at a glance
