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With HC, you have a reliable and prompt partner at your side who will meet your needs at all times. We assure you permanent availability of goods and complete documentation.
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!
Our digital platform supports a smooth flow of our processes. All information on orders and stock availability can be viewed directly at a glance.
We have established a comprehensive quality management system that ensures complete traceability of medical products at any time at the push of a button.
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.
Free shipping is just standard for us - as is the fact that you pay for the goods only after you receive them, of course.
If there is a reportable incident, we will assist you in compiling the report.
If you need to return the products, the return will also be free of charge.
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.
For the various players in the healthcare sector, this results in numerous obligations – distributors of medical devices have to ensure the following aspects in particular:
With HC, you have a partner ensuring all of this today at your side.
Our quality management, which is based on a digital warehouse control system and GDP certified logistics, fulfills all MDR requirements.
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.
The responsible authority assesses whether the planned safety measures are appropriate and monitors our implementation of the product recall or other safety measures.
After the product recall or other safety measures have been executed, we prepare a final report and send it to the responsible authority. We also provide a copy of this final report to users. We additionally inform the manufacturer about the completion of the procedure.
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.
The information provided by the manufacturer regarding possible planned immediate measures, the type of investigation and its expected timeline, along with information about the event, the affected product and the consequences for the patient, are provided to the respective authority within the specified deadlines as part of the initial notification. If necessary, an interim report will be required down the road.
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.
