Bridging continents –
Your European

healthcare logistics

Free consultation Explore our services
  • ISO 13485
  • EU MDR compliant

International MedTech companies trust Kalms Operations to manage their entire supply chain in Germany and Europe. From first shipment to full-scale distribution — flexible, certified, and built around your needs.

Free consultation Explore our services

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Why choose Kalms Operations?

One partner for logistics, import compliance
and market access across Europe

Entering Europe usually means juggling separate providers for warehousing, regulatory compliance and market access strategy — each with its own contract, contact and timeline. Kalms Operations brings logistics, MDR/IVDR Art. 13 importer services and market access consulting together under one roof, so compliance and commercial strategy move at the same pace as your shipments.

  • Central European hub

    Berlin provides direct access to the full EU market, Switzerland and non-EU destinations — with your Art. 13 importer function based on-site.

  • MDR/IVDR Art. 13 Importer

    We act as your official EU importer, keeping compliance, labeling and vigilance obligations directly linked to your logistics operation.

  • Reimbursement & market access strategy

    Structured guidance toward Germany's GKV reimbursement pathways, delivered through our market access partnership with Kalms Consulting.

  • One coordinated pathway

    No hand-offs between logistics, compliance and market access — one team keeps your product moving toward launch.

€ 43 Bn

German medical device market — 
the largest in Europe, accounting for 27% 
of the total EU market.

1400 +

MedTech companies active in Germany — Europe's most important healthcare market.

20 +

years of expertise in 
Healthcare logistics.

Kalms Operations

Built for companies taking healthcare into Europe

  • Established International companies

    expanding into Europe

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    Lifescience start-ups

    planning European clinical trials

  • Medical device, Diagnostics, and Biotech manufacturers

    launching their first EU operations

  • Local and International Distributors

    requiring EU distribution support

The Challenge

Entering Europe 
is complex?

It doesn't have to be

For medical device companies entering Germany and Europe, the operational hurdles are significant — regulatory compliance, local warehousing, multilingual customer service, and distribution logistics, all before your first sale. Without the right partner, companies waste months and capital on infrastructure they don't need to own.

  • Regulatory & quality compliance

    EU MDR, ISO 13485 — complex requirements with zero tolerance for error

  • No local infrastructure

    Setting up certified warehousing and customer service in Germany is slow and costly

  • Limited local market knowledge

    Business development and clinical education require deep local expertise and relationships

  • Large providers require scale you don't yet have

    Most 3PL providers set minimum volumes that exclude start-ups and smaller companies

OUR ANSWER

One partner for your entire European operation —
from day one

Kalms Operations is your Logistics Service Provider (3PL) specialized in MedTech and based in Berlin. Our modular service model is designed for international companies who want to enter Germany and Europe quickly, compliantly, and without building costly infrastructure. No minimum volumes, no long-term lock-in — just a reliable certified partner who knows the market.

  • ISO 13485
  • EU MDR compliant

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Our services

Everything your European operation needs

Modular services — take only what you need, scale as you grow. Combine them for
a complete European operation.

Gerald Schröder, Head of Kalms Operations

Contact us

Our friendly team would love to hear from you.

New Whitepaper

Master the daunting task of launching

in Germany and Europe

In our new Whitepaper, we list the 7 fundamental steps that your company can take to establish a successful operations in Germany and Europe. To know more, download our latest Whitepaper in PDF form by clicking on the button below.

Download our Whitepaper

Latest Blog Articles

The latest fair, industry news, technologies, and workshops.

Kalms Group to Attend Medical Fair Asia 2026 in Singapore

Kalms Group will be attending Medical Fair Asia 2026 in Singapore, supporting international healthcare and MedTech companies with integrated expertise in European market access, regulatory strategy, and operational execution.

Meet the Kalms Group team at MedtecLIVE 2026 in Stuttgart

We will be attending MedtecLIVE 2026 in Stuttgart, offering integrated expertise across regulatory strategy, market access, and operational execution for MedTech companies in Europe.

Meet the Kalms Group at DMEA 2026 
In Berlin

Kalms Group will be present at DMEA 2026 in Berlin, offering integrated support across regulatory strategy, market access, and operational execution for MedTech and digital health companies entering and expanding in Europe.
Image: AI generated

Expanded Warehousing to Support Faster, More Reliable Supply Chains

Kalms Operations expands warehousing capacity in Europe to support resilient supply chains for healthcare and MedTech companies. Improve lead times, availability, and distribution reliability across the EU.

Webinar with Intralink: Business Opportunities in Japan and South Korea

Explore MedTech and healthtech business opportunities in Japan and South Korea in this upcoming Kalms Academy webinar with Intralink, featuring expert insights on market trends, entry strategies, and local challenges.

Kalms Group at World Health Expo Dubai 2026

Kalms Group will attend World Health Expo (WHX) Dubai 2026, bringing together strategic advisory and operational expertise across MedTech, digital health, regulatory affairs, market access, and healthcare logistics. Meet our team in Dubai to discuss global market entry, compliance, and sustainable growth.

Kalms Group at MEDICA 2025: 
Visit Us in Hall 15 / E24

Join Kalms Group at MEDICA 2025 in Düsseldorf (Hall 15 / E24). We’ll present our expertise in Market Access, Regulatory Affairs, Healthcare Logistics, and MedTech commercialization across Europe and beyond.

Germany’s E-Invoicing in 2025: Key Changes and Business Preparation

Discover how Germany’s e-invoicing for B2B transactions impacts businesses, with insights on compliance, benefits, and readiness steps.

Kalms Group at MEDICA 2024: Visit Us at Hall 14 / D21

It is our pleasure to announce that we will once again be attending MEDICA 2024, taking place from November 14th – 17th at MesseDüsseldorf, Germany!

Unlocking Sustainable Logistics: Best Practices, Advantages, and Future Directions

Unlocking Sustainable Logistics: Best Practices, Advantages, and Future Directions

Meet our experts @ Medica 2022

It is our pleasure to announce that we will again be attending MEDICA, taking place November 14th – 17th, at Messe Düsseldorf!

The selling-off period or the interim between the certificates

The MDR has now become a reality for most manufacturers, importers and distributors in the medical device industry.

BREXIT and the supply of medical devices - if you're not prepared, take action now

Many companies in the EU and UK are not yet set up to shorten the longer delivery times after Brexit. Here's what you can do right now.

7 Steps to Successful Healthcare Logistics

Launching operations in Germany and Europe for your medical device or pharmaceutical company can be a daunting task. With this list of 7 steps from Kalms Operations, your company can start on the path to establishing successful operations in Germany and Europe.

Meet our experts @ Medica

All of our experts will be available for you to make an appointment with, Monday through Thursday during MEDICA from 10.00 - 16.00. Book Now! We are happy to have these experts at our booth and hope you will enjoy their knowledge and distinguished experience as well.

Visit Kalms Group at MEDICA 2019!

It is our pleasure to announce that we will be attending MEDICA.

Implementation of ISO 13485:2016 QMS

After a successful ISO audit, we are proud to announce that Kalms Operations has successfully implemented the ISO 13485:2016 Quality Management System!