Supporting your
healthcare business

from market entry
to market success

Your gateway to Europe

Kalms Consulting provides expert, incisive and hands-on guidance for medical devices, diagnostics, biotech, health IT, pharmaceutical and other healthcare companies. Since we are based in Berlin, we are able to support your business success in Europe, by applying our expertise of the German healthcare market and all other key European markets. We are your gateway to one of the largest medical technology markets in the world. Marco Kalms and his team have over 200 years of accumulated operational and strategic business experience in Europe, including sales and country management, as well as European management and various international leadership roles. We offer strategic and operational support in the fields of market access, health economics, reimbursement, regulatory compliance and business development.

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Experts in being partners

Your business is our business. So whether you need first ideas or a second opinion: we’re here to listen – and ready to answer

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The Kalms model
of innovation

Analytics – Strategy – Implementation – Execution – Continuous Improvement: This is how we define the roadmap to success. The Kalms Consulting team consists of experts with profound operational experience and various backgrounds. Our work does not stop when the analysis is completed and a market access or business development strategy is developed. Kalms Consulting supports their clients with its implementation. We work on behalf of the client; or in close contact with the client’s market access team.

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The best strategy: a strong team

We are working for your healthcare business today, tomorrow – and together: Our unparalleled collective of experts draw experience from all over the world and from different industries. Altogether we unite diverse experiences in the fields of parliament, politics, hard science, analytics and business.

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Industries we work for

Medical Devices and Diagnostics

Health IT



Regulatory Services

The EU/2017/745 (MDR) date of application is set for May 26th, 2020 and will be followed by the implementation of the in-vitro diagnostic regulation EU 2017/746 (IVDR) on May 26th, 2022. Navigating the changing regulatory environment of medical devices and In Vitro Diagnostics (IVDs) is challenging and a solid, but agile strategy is key for regulatory compliance.

Kalms Regulatory team assists you in utilizing compliance requirements as a business value and transform them into success. From initial design and development to management of medical devices and in vitro diagnostics, our services help clients to efficiently establish, implement and maintain all relevant framework processes and documents.

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