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MDR Compliance across the EU & UK

Why MDR compliance is the modern standard you should be following

For hospitals & health care organisations, MDR is an important set of rules that helps to ensure the safety and effectiveness of medical devices, requiring manufacturers demonstrate that their devices meet rigorous safety and performance standards.

MiS can assist in your compliance via our innovative services: from APIs & HL7/FHIR and interfacing, through to data capture and auditing, we have a robust system that scales to your needs, bridging the gaps between your legacy software and bringing them forward into the future.

Our MiS traceability software has been built to ensure our software and APIs follow the MDR standard using a modern, secure and efficient approach to verifying and auditing assets within your organisation.

The main features MiS enables for MDR compliance, but are not limited to, are:

  • Unique Device Identification (UDI) system: MiS generates, stores, and retrieves unique device identification (UDI) information for each medical device, whether that is in GS1, HIBCC, or, IFA.
  • Verified Suppliers: MiS can match your UDI assets against external sources like AccessGUDID, or EUDAMED, or your own internal verified inventory database.
  • Data accuracy: We're able to provide accurate and up-to-date information about patients (where applicable), medical devices (where most of our data is processed), and other equipment used or related to you, your patients, or other assets.
  • Data security: Ensure that data is protected and only accessible by authorized users in compliance with General Data Protection Regulation (GDPR)
  • Traceability: MiS is able to track and trace the history of medical devices, including details about the manufacturer, importer, and distributor, as well as any repairs, maintenance, or modifications made to the device.
  • Reporting and analytics: We provide reporting and analytics, which can help to identify trends and patterns, providing insights into the effectiveness of asset management, stocks, audits, and patient care.

This increased oversight is especially important for hospitals, as it helps to ensure that the medical devices they use are safe and effective. By using devices that have been thoroughly tested and evaluated, hospitals can be confident that they are providing the best possible care to their patients.