Industry MedTech
IT in medical technology.
Short answer
MedTech companies in Switzerland work under two regimes: the Swiss Medical Devices Ordinance with Swissmedic as supervisory authority and, for the EU market, the EU Medical Device Regulation.
01 Criticality
Why is IT critical in medical technology?
- Approval and market access depend on complete documentation.
- Software can itself be a medical device, with its own requirements.
- Growth into the EU brings authorised representatives, second registers and duplicate evidence.
02 Rules
Which rules are typically to be checked?
Whether a rule applies in an individual case depends on size, markets, customers and products. The situation picture clarifies this.
03 Services
How can I help?
The full version of this page: Full text as Markdown
What is the situation in your company?
Thirty minutes, no presentation.
