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.
Logistics & Warehousing
ISO 13485-certified 3PL and warehousing for third-party medical devices, IVD and biotech materials. Our Berlin facility offers temperature-controlled storage (−20 °C, 2–8 °C, 15–25 °C), humidity monitoring and a validated WMS. We handle customs clearance, bonded storage, inventory rotation, expiry control and returns, aligned to your SOPs. Hosting stock inside the EU cuts complexity and delivery times — asset-light for start-ups, audit-ready under ISO 13485 for global manufacturers.
- ISO 13485-certified storage & warehousing
- EU-based stock, faster delivery
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Customer Service & Fulfillment
Multilingual fulfillment services — order handling, picking, packing, returns and invoicing — tailored to healthcare and medtech companies. Outsourcing to Kalms Operations reduces complexity, adds scalability and guarantees full traceability. Our local teams answer calls and emails under your company name, with fast, personalised, multilingual communication reflecting European expectations. All activities comply with data-protection law, backed by CRM and reporting dashboards for transparency.
- Multilingual support under your brand
- Full traceability, GDPR-compliant
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MDR / IVDR Article 13 Importer
Kalms Operations unites the MDR/IVDR Article 13 importer role with ISO 13485 warehousing. We verify CE marking, labeling and the EU declaration of conformity, confirm the EU authorized representative, and link ourselves to the manufacturer in EUDAMED as importer of the products concerned. Every consignment then arrives in our own warehouse — so goods are checked while physically in our custody, and non-conforming stock never enters distribution.
- Importer & warehouse in one place
- Non-conforming stock stopped early
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Import / Export & Customs Clearance
Customs issues are the #1 cause of delay in international medical device supply chains. Kalms Operations takes the process off your desk: we prepare shipping documents and customs declarations, assign the correct commodity codes under the harmonised tariff and obtain binding tariff information, structure Incoterms with your carriers, and verify import requirements at the receiving end. Duties and import VAT are handled correctly — no border hold-ups, no cost surprises.
- Correct tariffs, no border delays
- No cost surprises on duties & VAT
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Clinical Trials Logistics
Launching a clinical study in Europe demands precision, speed and strict regulatory compliance. Kalms Operations delivers end-to-end clinical trial logistics for biotech products, IVDs and medical devices — import, customs clearance, controlled storage, temperature-controlled transport and last-mile delivery to trial sites, even for products without CE marking. Our ISO 13485-compliant Berlin facilities and network across the USA, UK, Middle East and Southeast Asia keep studies on time.
- End-to-end clinical trial logistics
- Global reach, Berlin-based
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Cold chain
Diagnostics, medical devices and laboratory chemicals are often temperature-sensitive and must stay within strict ranges to remain effective. Kalms Operations provides reliable cold chain solutions, from ISO 13485-compliant storage to validated packaging and monitored transport. Our Berlin infrastructure features state-of-the-art freezers, refrigerators and controlled ambient storage; qualified partners handle refrigerated, frozen, and ultra-low temperature requirements across Europe.
- Validated cold chain, all temp ranges
- Berlin infrastructure, EU-wide network
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Safety Testing and Field Service Engineering
Periodic safety inspections are mandatory for medical devices in Europe: the manufacturer sets the framework, the operator must carry the work out regularly. Kalms Operations provides electrically qualified staff to perform these inspections — at our facilities or directly in the hospital. We also support routine maintenance, installation and deinstallation of your equipment, including precise, timely transport in both directions. Small install base? We help even with low volumes.
- Qualified staff, on-site or in-house
- Support even for small install bases
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Tax and Business Consulting
Expanding into Europe raises tax questions long before the first sale: import VAT that must be charged and reclaimed, company taxation of a subsidiary, local payroll. Through our partnership with Rüter und Partner, Kalms Operations offers integrated tax and business consulting for international healthcare companies, including complex group structures. Their decades of experience with non-resident businesses and European subsidiaries complement our logistics and operational services.
- Integrated tax & logistics support
- Deep experience with EU subsidiaries
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Regulatory and Reimbursement Consulting
Kalms Consulting guides healthcare companies through Europe's complex regulatory and reimbursement environment. The team provides end-to-end consultancy for medical device manufacturers and selected services for pharmaceutical companies, focused on market access, pricing and approval strategy. By aligning reimbursement pathways with regulatory requirements and commercial objectives, products do not just reach approval — they achieve sustainable market
- Regulatory & reimbursement in one process
- Focused on sustainable market access
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Kalms Consulting
Supporting your healthcare business
from market entry to market success
Kalms Consulting offers a complete consultancy service for medical device manufacturers and selected services for pharmaceutical companies. They help create market success by determining the best way to reimburse your product.
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