It depends on the mandate. Founder Thomas Kempf, a certified auditor with board mandates and a Harvard credential in cyber risk management, supported by Lars Brunner, who leads medical and pharma.

rameus solutions

Q: What does rameus solutions do?

rameus solutions is a Swiss consultancy specialising in medical devices and SaMD (ISO 13485, MDR/IVDR) and information security (ISO 27001), with AI governance (ISO 42001) and board-level advisory alongside, from strategy to certified implementation.

Q: Where does rameus solutions work?

We are based in the greater Zurich area and work worldwide, with project experience across Europe, Asia, Africa and North America. We work in German, English and French.

Q: Do the EU AI Act, CRA, NIS2 and DORA apply to Swiss companies?

Often yes. Swiss companies are frequently affected through EU operations, customers or supply chains. We assess your exposure and build readiness on an ISO 27001 foundation.

Q: Can you both advise and implement?

Yes. We provide board-level strategy and oversight, then the same team carries out certified implementation, keeping advisory roles separate from certification-audit work.

scaled precision technology

Precision where it counts. Proven where it matters.

rameus solutions is a Swiss consultancy for medical devices and software as a medical device (SaMD), information security and AI governance. From strategy to certified implementation, worldwide.

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Precision, applied where it counts — worldwide. From our base in the greater Zurich area we help organisations bring medical devices to market, make information security certifiable, and bring technology risk to the boardroom, in German, English and French.

Medical Devices

Information Security

Boardrooms

Four fields, one standard of precision

Medical Devices & SaMD (ISO 13485)

Regulation is strategy. From requirement to market across ISO 13485, MDR/IVDR and SaMD.

Map your Pathway

Information Security icon — Information Security — ISO 27001 and the EU cyber regulations

Information Security (ISO 27001)

Build security once and reuse it everywhere – ISO 27001 through NIS2, CRA and DORA.

Start a gap analysis

AI Governance icon — AI Governance — ISO 42001 and EU AI Act readiness

AI Governance (ISO 42001)

Adopt AI without inheriting unmanaged risk. We turn ISO 42001 and EU AI Act readiness into working governance, at the pace your business needs.

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Strategy and Board icon — Strategy & Board — cyber, AI and technology risk at C-level

Strategy & Board (C-LEVEL)

Technology risk on the board agenda. Independent counsel you can own. We give boards and leadership teams independent counsel on cyber security, AI and EU regulation, then implement what they decide.

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Your advantage – our knowledge

Our team – two senior Specialists

Most technology advisors speak to engineers. Most board advisors don’t understand the technology. rameus solutions does both.

Thomas Kempf

Founder / CEO, Harvard Cyber Risk, Various board mandates

Lars Brunner

Senior Consultant Medical & Pharma, 15+ years IVD and GxP

Answers, not noise

Clear guidance from the people who audit and implement, not just write about it.guidance from the people who audit and implement, not just write about it.

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Common Questions – straight answers

What does rameus solutions do?

Where does rameus solutions work?

Do the EU AI Act, CRA, NIS2 and DORA apply to Swiss companies?

Can you both advise and implement?

Who leads the work?