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

Our Software as a Medical Device regulatory 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 & quote to explore your needs in detail.

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

Or send us your details and we will contact you:

Who we work with

Our clients come from across the industry and range from pre-start businesses to stockmarket-listed multinationals. We also have key strategic partners based in the UK and Denmark.

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.

    CEO, EU medical software company
  • Your service surpassed our expectations and added value across our organisation. We now feel much better placed to prepare for the MDR.

    Chief Executive, MedTech pre-start
  • A comprehensive, detailed and highly professional service.

    Regulatory Manager, UK device manufacturer
  • International

    We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.

  • Diversified

    Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.

Read more about our team and philosophy

Get our free White Paper: Software as a Medical Device — See whether the EU MDR applies to your application

Download

MDR Consulting

Our team of MDR professionals are medical device regulatory consulting specialists offering tailored MDR compliance services.

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.

FAQs

We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

Do you need help with your MDR strategy?

Contact us

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