SGS Benelux was able to issue the first MDR certificate to Serrix B.V, a manufacturer of medical devices, on Tuesday 25 July. Among other things, Serrix is a producer of Mycosan, which enables precision treatment of chalky nail and foot fungus. On behalf of SGS Benelux, Els Gillis, Business Developer Medical & Healthcare, presented the certificate to Irene Heijmans, RA/QA Manager at Serrix, and Ruben Visser, Managing Director at Serrix.
MDR (Medical Device Regulation) is the successor to MDD (Medical Device Directive) for CE Marking of medical devices. This standard provides all the frameworks and requirements that must be met before a CE Mark can be applied to medical devices. Medical device manufacturers have until May 2024 to submit their dossier to ensure products are certified according to the MDR standard and maintain their access to the European market.
Irene Heijmans and Ruben Visser: “At Serrix we strongly believe there is no greater wealth than health. It is our commitment to deliver safe and effective healthcare solutions that meet the highest standards of quality and regulatory compliance. The MDR certification signifies that our products have undergone rigorous assessments and adhere to the strict regulations, ensuring their safety, performance, and reliability for the long term, and strengthens Serrix' position as a reliable provider of consumer healthcare solutions.”
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