Software as a Medical Device Connected MDR systems for medical software compliance

Special application consulting services unlocking MDR compliance for software as a medical device.

Medical software compliance delivered by MDR specialists

All software products with an intended medical purpose are defined as a medical device under the EU MDR. This means that software developers need to build regulatory processes that mirror those of physical devices.

Our team of medical professionals are experts at applying medical device regulation to the unique situation of software as a medical device.

  • Unique MDR software service

    Unlike most providers, we have dedicated MDR services for medical software.

  • Free initial consultation

    We take time to fully understand your product before recommending any of our services.

  • Full-suite support

    We offer a full package of MDR services for software, meaning we can help at all stages of product development.

Our software compliance process

Mantra Systems' Software as a Medical Device process

We understand that regulatory processes need to function differently for medical software, so we offer a special application of our MDR consulting services.

Our full-suite MDR compliance service starts with a free consultation to explore your needs in detail.

Request free consultation

Integrated systems for data collection, reporting and analysis

Meet requirements for collection of performance data through our unique software PMCF registries and curated EDC systems.

We combine robust study design with full analysis and reporting services, providing all the evidence needed to support your MDR compliance.

  • Real-time data collection

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

  • Comprehensive CE-marking support

    Ensure your product is ready for CE-marking through working with our team of medical specialists.

  • Data analysis & technical documentation

    Full data analysis, reporting, and writing of MDR technical documents.

Call us now to discuss your MDR requirements:

(+44) 0114 386 3349

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MDR Consulting

Our team of medical doctors are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.

Download our free Software as a medical device White Paper


MDR Training

Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.

MDR Guidance

Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.

Do you have any questions about our MDR services?

Contact us