Kalms Consulting GmbH
Booth number: 2S05
www.kalmsgroup.com
About us
With extensive experience in the regulatory approval of medical devices, reimbursement, and commercialization, the Kalms Group supports established companies as well as start-ups in the fields of medical technology, (in vitro) diagnostics, BioTech and health IT from product idea to market entry and market success.
In addition, we provide fulfillment for manufacturers, including warehousing, logistics (3PL), cold chain, customer service, customs clearance, and device maintenance.
Furthermore, we develop and implement strategies in the areas of regulatory affairs, market access, reimbursement and governmental affairs.
Address
Rheinstraße 45-46
12161 Berlin
Germany
E-mail: info@kalmsconsulting.com
Phone: +49 30 405045310
Internet: www.kalmsgroup.com
101 Montgomery Street
Suite 1400
94104 San Francisco
United States
E-mail: info@kalmsconsulting.com
Phone: +49 30 405045310
Internet: www.kalmsconsulting.com
Contact person:
Products & Services
Kalms Operations Overview
Kalms Operations is an experienced Berlin-based healthcare operations and logistics partner helping international medical device, diagnostics, biotech and life sciences companies enter, expand and operate in Europe.
For companies from Asia and other regions looking for a practical gateway to the European healthcare market, we provide the operational infrastructure needed after regulatory planning: ISO 13485-compliant third-party logistics, warehousing, cold-chain solutions, MDR/IVDR importer support, clinical trial logistics, fulfilment, assistance with customs import and export, supporting VAT handling and customer service support.
By combining regulatory understanding, operational execution and a trusted partner network, we help companies establish a reliable European operational base without having to build every local infrastructure element on their own.
Our services are flexible, modular, and tailored to the needs of start-ups, SMEs and international manufacturers looking to move from market entry to scalable commercial distribution in Europe.
List of Services Offered by Kalms Operations:
Medical device third-party warehousing and logistics
Medical device cold-chain warehousing and logistics
Importer services under MDR/IVDR
Clinical trial logistics
Company representation and customer service support
Order fulfilment
Returns and complaint handling support
Customs, import and export coordination
Inventory and traceability management
Marketing and event logistics
Maintenance of electrical and electronic medical devices
Field service engineering
Business development and market access support through the Kalms Group network
Medical Device Third-Party Warehousing and Logistics
We provide third-party warehousing and logistics services for medical device, diagnostics, biotech and healthcare companies entering Europe or scaling their European operations. Our ISO 13485-compliant processes support secure storage, inventory management, distribution, customs coordination, returns handling and product traceability. As a practical gateway to Europe, we help companies establish a reliable operational base without building their own logistics infrastructure from the start. This enables more responsive, scalable, and reliable operations in regulated European healthcare markets.
Medical Device Cold-Chain Warehousing and Logistics
We offer cold-chain warehousing and logistics solutions for temperature-sensitive healthcare products entering or moving within Europe, including diagnostics, medical devices and selected life sciences products. We support controlled storage, validated packaging, monitored transportation, and documentation to help maintain product conformity throughout the supply chain. Our cold-chain capabilities include qualified temperature ranges, digital monitoring, and coordination with experienced transport partners. This gives international companies a dependable gateway to European cold-chain distribution and helps ensure reliable delivery across regulated healthcare markets.
Importer MDR/IVDR
We as an EU importer under MDR Article 13 and IVDR Article 13 for non-EU manufacturers placing medical devices or IVD products on the European market. Our importer services support documentation checks, product traceability, labelling requirements, EUDAMED-related activities, and coordination with manufacturers, authorized representatives and distributors. The service is integrated with our warehousing, logistics and customer support capabilities, creating a practical operational framework for European market entry. This helps manufacturers connect regulatory responsibility with controlled physical distribution and establish a structured route into Europe.
Clinical Trial Logistics
We provide clinical trial logistics for investigational products, diagnostics, and medical devices used in European studies. Our services include import coordination, customs clearance, secure storage, temperature-controlled handling, shipment preparation, and delivery to trial sites. We understand that entering Europe for clinical research requires precise timing, reliable documentation, traceability, strict observation of all agreed processes and close coordination with sponsors, CROs and study partners. By combining operational project management with healthcare logistics experience, we help clients keep European trial-related processes controlled, compliant and on schedule.
Company Representation and Customer Service Support
We support international healthcare companies with local company representation, customer service and fulfilment support in Europe. Our multilingual team is the front-line contact for customers, distributors, healthcare professionals and partners, including communication under the client’s company name where required. Services may include order handling, invoicing support, returns coordination, complaint handling support, reporting and customer communication. This enables companies to build a trusted local presence, respond professionally to customers in their local language, and create a consistent, high-quality service experience across European markets.