SaMD Medical Device Software

Special application consulting services unlocking MDR compliance for Software as a Medical Device

Our SaMD Medical Software services

All software products with an intended medical purpose are defined as a medical device under the EU MDR. Our team of medical professionals are experts at applying the Medical Device Regulation to the unique situation of SaMD.

  • Dedicated MDR software service

    MDR compliance services developed specifically for medical software.

  • Comprehensive CE-marking support

    Our 360° regulatory assistance ensures your product is ready for CE-marking under the MDR.

  • Technical documentation & data analysis

    Our experts write CERs, PMCF Plans and other technical documents for MDR compliance.

  • Real-time PMCF data collection

    Our EDC system's API allows automated, real-time data collection directly from your application.

Start today

Our in-house medical experts have extensive experience developing tailored SaMD regulatory systems. Start with a free MDR support session so we can fully address your needs.

Book a free MDR support session with one of our team

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