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What we can offer for your Start-Up company

EU Access Market for medical devices

EU Access Market for medical devices

The European medical device market is estimated to make up 27.3% of the world market.

In Europe, medical devices and IVDs are regulated respectively by Medical Device Regulation (MDR) (EU) 2017/745 and In-Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. And only CE marked medical device can be sold in Europe .

We can support you in:

CE-marking process,
appoint AR Representative in order to place your device in EU,
plan, conduct clinical studies before placing you medical device on the market including regulatory strategy development, study planning, application submission and study monitoring in EU member state,
support with European Post-market Clinical Follow-up Studies (PMCF) in EU member state.

Freelance medical devices in Switzerland

Freelance professional service

Struggling with the QMS documentation, need part-time support in the company or limited budget for resources?

We offer part-time/ certain time period support for your company (e.g., QMS projects, documentation support, on-site/remote audit)

QA for Start up

Why ConsMed?

Europan team with QA&RA experience in medical device industry.

Based in Switzerland and speaking EN, DE, PL.

Fair pricing and transparency.

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