We implement a robust medical device management systems, ensuring compliance with ISO 13485, ISO 27001, NEN 7510-1 and others for quality and information security.
Whether you manufacture medical devices or operate as an economic operator (e.g., importer, distributor, repackager, OEM supplier), implementing a medical device management system can support regulatory compliance. The most widely adopted medical device quality management system (QMS) is ISO 13485 for medical devices, though regional variations exist (e.g., in the US, Canada, Brazil, and Australia). For manufacturers entering multiple markets, the Medical Device Single Audit Program (MDSAP) can further streamline compliance and, in some cases, is mandatory.
As digital data storage and post-market surveillance increase, information security is becoming more critical. ISO/IEC 27001 (and NEN 7510-1 in the Netherlands) provides a framework for an information security management system (ISMS) tailored to medical devices. Beyond a QMS and ISMS, management systems can be extended to include Good Clinical Practice (GCP), Privacy Management (ISO/IEC 27701), and Good Machine Learning Practices (GMLP).
At MedQAIR, we specialise in implementing the best management systems for medical devices, covering quality management, information security, and compliance with evolving AI regulations. Our expertise includes ISO 13485, ISO 27001, and NEN 7510, ensuring compliance across design, development, distribution, and post-market surveillance.
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