Quality and regulatory support

Producing medical products with increasingly stringent requirements is a specialty that requires specific knowledge and experience. For organizations that develop new products, it becomes more and more difficult and costly to convert these products to regular production processes in accordance with the applicable guidelines. HCM Medical specializes in operating the manufacturing process as well as all associated quality aspects.

HCM Medical has a BSI certification for ISO 13485:2016 , a WVKL recognition as a tissue establishment, a GMP Certificate for Human Investigational Medicinal Products and a NVWA recognition for the manufacturing of medical devices from category 3-material according to Article 23 of Regulation (EC) no. 1069/2009.

How we
can help you

With HCM Medical’s MDR registration support, you can have confidence that your medical devices will be compliant with the latest EU regulations. Our expert team will handle the complexities of MDR, allowing you to focus on innovation and growth while ensuring your devices are available in the EU market as quickly as possible.

Contact us today to discuss how we can support your MDR registration journey and ensure the success of your medical devices in the European market.

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Our Location

Kerkenbos 10-113
6546 BJ Nijmegen
The Netherlands

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Contact us for expert support in medical manufacturing, innovation, and regulatory compliance solutions.