---
titel: "IT for MedTech in Switzerland: MDR, MedDO, ISO 13485 · SACOSI"
url: https://sacosi.ch/en/industries/medtech
seite: /en/industries/medtech
stand: 2026-09-24
beschreibung: "IT strategy for MedTech companies in Switzerland: MedDO and Swissmedic, EU MDR with third-country status, ISO 13485 and 27001, documented for audits."
---

> Knowledge version of the page https://sacosi.ch/en/industries/medtech. It contains the full text, including what is shortened or collapsible on the page itself. Publisher: SACOSI, Situational Awareness Consulting by Ivo Schönberner, Zürich.

# IT in medical technology.

**Short answer:** MedTech companies in Switzerland operate under two regimes: the Swiss Medical Devices Ordinance (MedDO), with Swissmedic as the supervisory authority, and, for the EU market, the EU Medical Device Regulation (MDR). Since 26 May 2021, Switzerland has been treated as a third country under this regulation. IT supports quality management, traceability and the security of software and connected products. I align it so that the evidence for audits and approval arises directly from operations.

## 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, a second register and duplicate evidence.

## Which rules typically need to be checked?

Whether a given rule applies in an individual case depends on size, markets, customers and products. The situation picture clarifies this.

### [EU Medical Device Regulation (MDR)](https://sacosi.ch/en/regulation#mdr)

**Switzerland:** Swiss law: Medical Devices Ordinance (MedDO), supervised by Swissmedic. For the EU, Switzerland has been treated as a third country since 26 May 2021. **EU:** Applies since 26 May 2021.

### [ISO 9001](https://sacosi.ch/en/regulation#iso9001)

**Switzerland:** Voluntary, often required contractually. **EU:** Voluntary, often required contractually.

### [ISO/IEC 27001](https://sacosi.ch/en/regulation#iso27001)

**Switzerland:** Voluntary, often required contractually. **EU:** Voluntary, often required contractually.

### [Cyber Resilience Act (CRA)](https://sacosi.ch/en/regulation#cra)

**Switzerland:** Applies to Swiss manufacturers selling products with digital elements in the EU. **EU:** Reporting obligations since 11 September 2026, full application from 11 December 2027.

### [Swiss Federal Act on Data Protection (FADP)](https://sacosi.ch/en/regulation#revdsg)

**Switzerland:** Applies since 1 September 2023. **EU:** Does not apply directly.

### [EU General Data Protection Regulation (GDPR)](https://sacosi.ch/en/regulation#dsgvo)

**Switzerland:** Applies to Swiss companies that offer goods or services to individuals in the EU or monitor their behaviour. **EU:** Applies since 25 May 2018.

### [EU AI Act](https://sacosi.ch/en/regulation#aiact)

**Switzerland:** Applies to Swiss providers that place AI systems on the EU market or whose outputs are used in the EU. **EU:** Phased in since 2 February 2025.

## How can I help?

### [Situation picture for investments](https://sacosi.ch/en/investors)

IT due diligence before the investment, or the situation picture in the first weeks afterwards: risks, costs, dependencies and obligations of the investment on a single page, with measures ranked by impact and effort.

### [Fractional CTO for a defined period](https://sacosi.ch/en/fractional-cto)

Technical leadership for a defined period: architecture, team, security, due-diligence readiness. The goal is a handover to a permanent CTO or the company's own team.

### [Compliance roadmap](https://sacosi.ch/en/regulation)

Which standards and laws apply to your business, in what order to address them, and how the evidence is built up in an auditable system, for example for ISO 27001, ISO 9001 or TISAX.

### [Scaling architecture](https://sacosi.ch/en/it-architecture)

A target architecture without legacy baggage that supports the planned growth: identity, workplace, cloud, local AI, costs in proportion to budget.

Back to the [industry overview](https://sacosi.ch/en/industries) or the [overview of all rules](https://sacosi.ch/en/regulation).

## What is the situation in your company?

Thirty minutes, no presentation. You describe the situation, I ask questions. Afterwards, we both know whether a situation picture is worthwhile.

CH +41 78 251 09 69 DE +49 152 27602667 ZRH 47.3769°N · FRA 50.1109°N · German, English