Certified. Reliable.
Goal-oriented.

Certified wholesale according to GDP & ISO 13485. Conformity according to Article 16 MDR.

As a distributor of medical devices and pharmaceutical products, we bear a decisive responsibility within the supply chain – not only for quality, but also for compliance with legal requirements.

That is why we rely on a certified quality management system in accordance with GDP, ISO 13485 and act strictly in accordance with the requirements of the EU Medical Device Regulation (MDR).

Our responsibility - your safety:

Certified according to ISO 13485 & GDP (Good Distribution Practice)

Our quality management system meets the specific requirements for companies in the medical device and pharmaceutical industries. It ensures that our processes – from goods receipt to storage and dispatch – are documented, checked and continuously improved.

MDR-compliant action in accordance with Article 16

As a distributor who carries out activities in accordance with Article 16 MDR (in particular relabeling or translation of instructions for use), we observe the special obligations. We ensure that every modification complies with the law, that the product labeling is retained and that conformity is not impaired.

Complete traceability

We document all products and batches in full, ensuring that fast and transparent traceability is possible at all times.

Risk and process management

We assess risks along the entire supply chain and implement measures to prevent quality or safety deficiencies.

Reliable partner for manufacturers and healthcare facilities

We take responsibility for the proper provision of medical devices on the market – safely, legally compliant and efficiently.

Rely on certified quality and MDR compliance - for safe, responsible trade in medical devices and pharmaceutical products

Experienced. Efficient.
Committed.

Parallel import and distribution of medical devices – safe, transparent and MDR-compliant.

As a specialized provider in the parallel import and distribution of medical products, we ensure that all products are distributed under the highest quality and safety standards. We fulfill all requirements of the EU Medical Device Regulation (MDR) and the obligations under Article 16 MDR.

Our standards - your advantage:

Legally compliant import and marketing

In the case of parallel imports, we obtain medical devices from other EU/EEA countries and place them on the market without changing their technical properties. In doing so, we ensure that the products have been lawfully placed on the market in the country of origin.

Labeling and language adaptation according to Article 16 MDR

We make the necessary adjustments, such as labeling and translating the instructions for use into the local language, and document all changes in accordance with the requirements for economic operators.

Quality management according to ISO 13485 & GDP

Our processes are certified – from incoming goods inspection to relabeling and delivery. In this way, we guarantee maximum transparency and traceability.

Cooperation with notified bodies and manufacturers

As part of parallel distribution, we coordinate any necessary changes transparently with all parties involved to ensure the integrity and safety of the products.

With our experience in parallel import and distribution, we provide you with access to high-quality medical devices - efficiently, legally compliant and in compliance with all regulatory requirements.