DISTRIBUTORS AND IMPORTERS CARRY A LOT OF RESPONSIBILITY
The new MDR regulation puts the pressure on distributors and importers, and not only on medical device manufacturers. Distributors and manufacturers are forced to actively ensure and review the compliance of the medical devices they sell. Our team has made significant efforts for several distributors and importers as well as companies with both roles. We work with both small companies and companies with turnovers running into the tens of millions of euros.
We have built a complete medical device quality management system for various distributors as well as created processes where the compliance of the sold products is inspected. We have also been involved in turning distributors into manufacturers so that they can better serve their customers.
Our company can operate as the local representative for healthcare products from outside the EU. We take care of the bureaucracy related to placing products on the market and keep the CE marking up to date.
Our distributor client wanted to enter the markets with its new product. We implemented the integration of an ISO 13485-compliant quality management system on top of the existing quality management system. We completed the integration and led the certification audits. Next, we completed the technical documentation of the client’s new product and carried out approval tests and certifications for the CE marking.
The client got a product of its own alongside the distributed products in a quick schedule. The client’s product responded to the needs of the customers in the client’s market area much better.
Our manufacturer client wanted to become an importer and distributor alongside its own manufacturing to offer its customer a better service package. We made the necessary expansions in the client’s ISO 13485-compliant quality handbook, process guidelines and work instructions. At the same time, we ensured that articles 13 and 14 of the MDR were considered in the company’s new operations. We trained the employees in all the new processes and operating procedures.