MDPROJECT

Meeting the rigorous regulatory demands for medical devices is paramount for successful market access. At MDProject, we offer comprehensive assistance for both non-active and active medical devices, ensuring compliance with global regulations such as EU MDR / IVDR and 21 CFR Part 820. Our expertise spans across various domains, enabling us to tailor your quality management system to align seamlessly with the ISO 13485:2016 standard, a pivotal foundation for compliance... For non-active medical devices, we specialize in batch production, process validation, cleanroom environments, sterilization processes, clinical evaluation and biological safety. Our adept team diligently helps to construct technical documentation, while providing hands-on guidance to implement a robust quality management system. We navigate the complexities of EU MDR / IVDR and 21 CFR Part 820, ensuring your product aligns with stringent standards... When it comes to active medical devices, we provide the same..

Registration numbers: 27326333 (W), 555778310 (W)

VAT numbers: NL819900473B01, NL851771683B01

Primary location: Alphen Aan Den Rijn Netherlands