Our Quality Promise

We have made it our mission to optimize the flow of goods and offer the same quality at better prices.

Quality is our highest priority

Mit HC haben Sie einen zuverlässigen und schnell agierenden Partner an der Seite, der Ihren Bedürfnissen jederzeit gerecht wird. Wir sichern Ihnen dauerhafte Warenverfügbarkeit und lückenlose Dokumentation zu.

Patient safety is our top priority - we therefore guarantee product traceability at all times.

With all this HC stands for the utmost safety, excellent service and flexibility!

 

Digitales Warenwirtschaftssystem

Our digital platform supports a smooth flow of our processes. All information on orders and stock availability can be viewed directly at a glance.

Lot documentation

We have established a comprehensive quality management system that ensures complete traceability of medical products at any time at the push of a button.

Availability of goods

We guarantee permanent availability of goods. For this purpose, we stock the 3-month requirements of the respective customer. The selected product portfolio is individually available for our customers.

Order to Cash Process

Free shipping is just standard for us - as is the fact that you pay for the goods only after you receive them, of course.

Damage report

If there is a reportable incident, we will assist you in compiling the report.

Free return shipping

If you need to return the products, the return will also be free of charge.

We comply with all legal requirements for trading with medical devices

Thanks to the digitalization and certification of our processes, we guarantee security, transparency and efficiency. We continuously check our quality management processes. Therefore, you can rely on us to not only meet all current, but also all future legal requirements.

This also applies to the so-called “Medical Device Regulation – MDR”, which has to be applied starting from May 26, 2021.

This is an EU regulation, which is valid in all EU member states and all countries associated with the European domestic market.

The MDR is a law that is focused on protecting the consumer or patient. The regulation not only governs the tasks and obligations of all economic actors and healthcare facilities in all of Europe, but also focuses on the entire life cycle of medical devices.

EU MDR
QA Quality Assurance and Quality Control Concept

We meet the MDR requirements for distributors

Für die unterschiedlichen Akteure im Gesundheitswesen ergeben sich daraus zahlreiche Verpflichtungen – Händler von Medizinprodukten müssen insbesondere folgende Aspekte gewährleisten:

  • Distributors have to fulfill comprehensive traceability and control obligations and have to work closely with manufacturers and upstream suppliers to do so.
  • Distributors have to ensure that the required product-specific storage and transport conditions are adhered to. This includes the need for distributors to ensure that the manufacturer's storage and transportation specifications for the product in question are adhered to for the entire time that it is under the distributor’s responsibility.
  • The regulation includes comprehensive requirements on controls and storage. Distributors have to organize their inventory management in order to have an accurate overview of their goods and their condition at all times. This implies the task of a detailed documentation.
  • At the same time, distributors are obliged to document which products they have delivered to which customer or partner and when.
  • Außerdem müssen Händler Beschwerden von Anwendern und Patienten erfassen, dokumentieren, auswerten und weiterleiten. Die maximale Meldefrist für damit verbundene Vorkommnisse wurde auf 15 Tag halbiert.

With HC, you have a partner ensuring all of this today at your side.

Quality management: Our digitalized and certified processes

Unser Qualitätsmanagement, das auf einem digitalen Warenwirtschaftssystem und einer GDP zertifizierten Logistik basiert, erfüllt alle Anforderungen der MDR.

  • Unser Warenwirtschaftssystem garantiert jederzeit die vollständige Rückverfolgbarkeit aller Produkte via Chargen. Auf Knopfdruck können wir jederzeit sagen, welche Charge wir wann von wem bezogen und wann an wen geliefert haben. Basierend auf einer Cloud-Lösung haben wir jederzeit von überall Zugriff auf sämtliche Daten.
  • Unser Warenlager ist GDP zertifiziert und temperaturgeführt. Die vom Hersteller vorgegebenen Lagerbedingungen werden daher jederzeit garantiert, auch während des Transports, der über unsere GDP-zertifizierten Partner erfolgt.
  • Auch unsere Wareneingangskontrollen sind GDP-zertifiziert. Sowohl physisch als auch in unserem Warenwirtschaftssystem werden Produkte – sofern nötig – direkt in einem Sperrlager getrennt. Die Lagerhaltung erfolgt mittels unseres Warehouse Management Systems Scanner geführt. Über eine elektronische Schnittstelle mit Echtzeit-Anbindung erfolgt die automatische Lager-Synchronisation mit unserem Warenwirtschaftssystem. 

We meet the MDR requirements for distributors

Notification and procedure in the context of a product recall

In accordance to the applicable regulations, we are obliged to notify about product recalls. This notification is made by us both to the responsible authority of the respective country and to the affected users.

Directly upon publication, we receive, among other things, the recall lists of the German Federal Institute for Drugs and Medical Devices (BfArM). They are automatically matched with the products and batches in our inventory control system.

If such notifications are received – just as in the case of direct notifications by manufacturers or partners such as suppliers – we check whether we have delivered products affected by the recall or other safety measures. If we are not affected, we inform the information provider (manufacturer, supplier, etc.).

If we are affected, we will contact affected users directly by notifying them of the product recall or other safety measures in writing and initiate them. At the same time, we will notify the responsible authority in the respective country of the product recall or other safety measures. The notification to the relevant authorities is made using the appropriate forms. We also provide users with a copy of this initial notification.
The responsible authority assesses whether the planned safety measures are appropriate and monitors our execution of the product recall or other safety measures.

Die verantwortliche Behörde beurteilt, ob die geplanten Sicherheitsmaßnahmen angemessen sind und überwacht die Durchführung des Produktrückrufs oder anderer Sicherheitsmaßnahmen durch uns.

Nach erfolgter Durchführung des Produktrückrufs oder anderer Sicherheitsmaßnahmen erstellen wir einen Abschlussbericht und senden diesen an die zuständige Behörde. Diesen Abschlussbericht stellen wir parallel auch dem Anwender als Kopie zur Verfügung. Außerdem informieren wir den Hersteller über den Abschluss des Verfahrens.

Notification and procedure in the context of an incident

In accordance with the applicable regulations, we are obliged to notify about serious incidence. This notification is made by us to the responsible authority of the respective country.

As soon as we receive notification about a serious incident from the user, we contact the manufacturer of the product directly or indirectly to inform them about the incident and, if necessary, to send them the product and accessories for investigation purposes.

Either by us or its contractual partner, the manufacturer will be requested to state whether immediate measures are planned as a result of the incident, what type of investigation is planned by the manufacturer and by when the result of the investigation and an associated final report can be expected.

Die Informationen des Herstellers bezüglich möglicherweise geplanten Sofortmaßnahmen, zur Art der Untersuchung und deren voraussichtlichen Zeitablauf geben wir verbunden mit den Informationen über das Ereignis, das betroffene Produkt, sowie die Folgen für den Patienten im Rahmen der Erstmeldung innerhalb der festgelegten Fristen an die zuständige Behörde. Gegebenenfalls wird im weiteren Verlauf ein Zwischenbericht erforderlich.

As soon as all investigations have been completed by the manufacturer and submitted to us, we will send a final report to the competent authority. It contains all the information that was not available at the time of the initial notification – in particular, the results of the investigations, the conclusions, any planned corrective measures and the approximate timeline for their implementation.

All notifications to the responsible authority are made by us are made using the appropriate forms. We also provide a copy of all notifications to the user. At the same time, the manufacturer is informed accordingly.