Medical Devices & SaMD

Q: What does rameus solutions do for medical devices?

We take medical-device and software-as-a-medical-device organisations from requirement to market: ISO 13485 quality systems, MDR and IVDR conformity, software as a medical device and IEC 62304, computer system validation and ISO 14971 risk management.

Q: For medical devices, why is regulation strategy?

Because the regulatory pathway shapes the product, the timeline and market access. Deciding it early and deliberately keeps momentum; leaving it late turns it into a costly constraint.

Q: Do you cover Swiss market access?

Yes. Switzerland is a third country under the EU MDR and IVDR, so market access, including a Swiss authorised representative, is part of the work we plan with you.

Q: Who leads the medical and pharma work?

Lars Brunner, a certified lead auditor and ISO 13485 quality manager with more than fifteen years in medical, pharma and IVD quality and regulatory roles, and a PRRC and Responsible Person. See Lars Brunner.

Q: Where should we start?

Usually with the intended purpose and classification of the device, which determine the pathway, and a gap analysis against ISO 13485 and the applicable regulation.

Bringing a medical device or in-vitro diagnostic (IVD) to market — and keeping it there — depends on a quality management system and regulatory compliance that hold up to scrutiny. rameus solutions supports Swiss medical-device, IVD and software organisations across the full picture: ISO 13485, MDR and IVDR, software as a medical device, software validation and risk management. Our work is led by specialists who have built quality systems, prepared regulatory documentation and audited them.

Where we help

ISO 13485

Build and maintain the medical-device quality management system

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MDR / IVDR for Swiss manufacturers

Nnavigate Switzerland’s third-country position and the Swiss ordinances

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SaMD & IEC 62304

Software as a medical device and the software lifecycle

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Software validation (CSV)

Validate software in your QMS, production and devices

CSV – NOW!

ISO 14971

Risk management across the device lifecycle

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About us

The experts behind the services.

Who we are

Why rameus

This cluster draws on two complementary specialists. Lars Brunner brings deep quality and regulatory experience — ISO 13485, MDR/IVDR, and the Responsible Person (RP) and PRRC roles, including for Swiss Authorised Representatives. Thomas Kempf brings medical-device and IVD development, software and audit experience, having contributed to bringing diagnostic instruments to market. Together they cover the full path from science to system to certificate.

rameus solutions is the right partner when

you are bringing a medical device to market and need a QMS built to ISO 13485 — without an in-house regulatory team. Our consultants hold ISO 13485 lead-auditor certification and have hands-on experience in IVD development. We know the standard not from theory but from audit practice across Switzerland and Germany.

FAQ

What does rameus solutions do for medical devices?

For medical devices, why is regulation strategy?

Do you cover Swiss market access?

Who leads the medical and pharma work?

Where should we start?

Bringing a device to market, or keeping it compliant?

Talk to us