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Our goal is to develop and produce devices in such a way that they pass the required certification from the first time.


Our involvement in certification

Guidance in certification processes

Our team offers expert guidance to clients throughout the certification process. We specialize in navigating and applying the complex regulatory requirements, ensuring a streamlined and efficient path to certification.

Focus on a range of CE markings

We have extensive experience in guiding clients through the CE marking process for various directives and regulations. This includes MD, LVD, RED, EMC, MDR, and IVDR, ensuring adherence to essential European standards. Our expertise ensures that your project meets all regulatory requirements for a successful certification.

Access to FDA

Our Quality Management System is ISO13485 certified and made compatible with the 21 CFR Part 820 required for FDA.

Our approach to managing certification

Collaboration with accredited test houses

We maintain strong partnerships with a network of accredited test houses. This collaboration is essential for conducting the necessary testing to ensure that hardware products meet the required standards for certification.

Conducting root cause analysis for increased reliability

Our approach includes conducting thorough root cause analysis to investigate faults in devices. This process significantly contributes to the reliability and trustworthiness of the final product, ensuring it meets not only the regulatory standards but also the high-quality expectations of the market.

Technical file and FDA 510(k) preparation for CE certification

A critical step in the certification process is the preparation of technical files for CE certification and 510(k) submission for FDA. We offer assistance in this area, addressing the needs and concerns many clients have about this crucial stage.

Ensuring quality

Highlighting ISO 13485 Certification

Our ISO 13485 certification, indicative of our extensive experience in quality management systems for medical devices, is a testament to our commitment to excellence. This certification is prominently displayed to assure clients of our credibility and depth of expertise in the field

Emphasizing the Importance of Compliance to Clients

At Comate, we stress the importance of certification and regulatory compliance. We recognize its overarching significance, extending beyond the medical field to encompass all products requiring CE and FDA marking. Compliance is not just a regulatory necessity; it is integral to the quality and safety of the products in the market.

Do you have a Certification question?

Let's get in touch with our experts. We're happy to help shed some light on an often complex process.