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Medical Device Software Quality Innovation

HTD experts have industry knowledge and experience to seamlessly deliver SaMD products that meet regulatory requirements, deliver value to their users, and save patients' lives. Avoid medical device software development mistakes and accelerate innovation while decreasing cost and time to market with HTD

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Unlock SaMD Success: From ideation to FDA submission

HTD is your trusted partner in medical device software development. We specialize in navigating the highly regulated Software as a Medical Device space. Our expert teams support you throughout the entire product life cycle: from product development to risk classification, usability engineering, quality advisory, Design Control Management, compliant agile development, and FDA guidance. Let us help you bring your innovative medical software to market with confidence and compliance. We help you accelerate innovation by delivering life-saving SaMD products.

Let's work together on:

  • Follow compliant agile to ensure your device is safe and will be on the market in no time!

  • Design patient-facing software experiences that drive change to improve lives.

  • Create optimal regulatory strategy to accelerate time to market.

  • Smart on FHIR healthcare

    Lead FDA Submission including documentation and communication so that you can focus on the rest.

  • Optimize interactions between people and devices to minimize errors and improve experiences.

  • Set up and manage medical device design controls with full traceability to ensure compliance

  • Analyze your QMS and plan what we need to do to comply with regulations.

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 In the meantime, check out some relevant HTD Insights articles.

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Schedule a consultation with our specialist


Digital Health Principal

Weronika Michaluk

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HTD has served 100+ top companies across healthcare


Nitin Gujral

HTD's deep knowledge of healthcare and healthcare IT made them an ideal partner for developing our new mobile app. Leveraging their expertise in the most current consumer grade frameworks and technologies, we were able to accelerate our timeline and decrease project risk. We'd highly recommend HTD for any healthcare product development needs.

Nitin Gujral

Director of Software Engineering and R&D
Innovation and Digital Health Accelerator
Boston Children's Hospital