After an intense journey of collaboration, we are proud to announce the successful transition of 13 technical files for disposable products and 13 technical files for medical equipmentto full MDR compliance.
MDR (Medical Device Regulation) is the EU Regulation 2017/745 on medical devices that replaces the previous Medical Device Directive (MDD). It introduces more stringent regulatory requirements to ensure greater safety, traceability, and transparency for all medical devices marketed in the European Union.
This achievement reflects our commitment to patient safety, regulatory excellence, and the highest quality standardsin the medical device industry.
A huge thank you to our incredible teamfor their hard work and resilience demonstrated throughout this challenging but rewarding process.
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