Technology that saves lives
Medical devices are growing more connected, more intelligent and, with that, more complex. This is exactly where we have felt at home for more than four decades.
We guide manufacturers from the first idea through safe market release to live operation, with certified processes, proven platforms and a team that speaks the language of the regulators.
- ISO 13485
- ISO 14971
- IEC 60601 series
- IEC 62304
- IEC 82304
- IEC 62366
- IEC 81001
- MDR
- FDA 21 CFR
You decide where we step in.
From the first workshop and tailored Consulting through to taking full ownership of your innovation project. You decide how we can best support you.
Get audit-ready, faster
We equip your organisation to meet standards and regulation with confidence: hands-on Consulting, training that sticks and standard-compliant structures for lasting compliance. The foundation for safe medical device Development.
From requirement to approved device
Engineering services that run from the first requirement to the approved product. We support you with individual experts, a dedicated team, or take on entire Development projects.
Keep your device safe after launch
Safe operation in medical technology: obsolescence management, secure further Development and cybersecurity once the product is live. We take on safe operation and free you up for the next generation of devices.
Our building blocks for your safe medical device
End-to-end support for medical devices up to risk Class IIb, certified to ISO 13485. We cover safety, security and usability, and stay with you across the whole process.
Decades of experience in medical technology.
We measure success by what happens after approval: stable devices in the field, happy audit teams and predictable releases.
Into series faster. With certified platforms.
Learn more.
Let us talk about your medical device.
We listen, get a clear read on your case and tell you honestly whether and how we can help.