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Software as medical device (SaMD)

Empower device innovation with an experienced team. HTD brings technical, quality & regulatory expertise to support you from product ideation all the way to FDA submission.

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our focus

Engaging software for next-generation medical devices

In the ever-evolving landscape of healthcare technology, medical devices have become integral components of a connected ecosystem, empowered by cutting-edge software solutions.

At our company, we specialize in developing engaging software for next-generation medical devices. Our mission is to revolutionize patient care by harnessing the potential of Software as Medical Device (SaMD). These advanced systems have redefined the boundaries of medical technology, enabling comprehensive care platforms that are adaptable to various clinical settings or even for use by patients at home.

With our expertise in health IT integrations and design for behavior change, we ensure the effectiveness and success of SaMD systems. Our team at HTD possesses extensive experience in designing software applications that cater to the needs of both patients and healthcare professionals.

We are committed to helping you overcome the challenges of developing Software as Medical Devices and delivering solutions that instill trust and confidence. Together, we can transform healthcare by pushing the boundaries of innovation and redefining patient-centric care.

  • Compliant agile development catered specifically to the FDA regulated industry, enabling iterative and efficient software development while maintaining compliance with regulatory requirements. We help you embrace the benefits of agile methodologies, delivering high-quality medical device software with increased speed, adaptability, and regulatory adherence.

  • Expert guidance in navigating medical device software development, will help you ensure regulatory compliance and industry best practices. With a strong emphasis on quality, & robust processes we assure safe and reliable software performance, benefiting patients and healthcare providers.

  • Our profound expertise in human factors and usability engineering enables us to create medical devices that seamlessly integrate into users' workflows and deliver a superior user experience. By leveraging our knowledge in this field, we ensure that our clients' products are intuitive, efficient, and designed with the end-user in mind.

  • With our deep expertise in data management and integrations we enable seamless connectivity and interoperability with various healthcare systems and data sources. Our solutions empower healthcare providers to harness the full potential of data, facilitating informed decision-making, personalized care, and improved patient outcomes within their SaMD ecosystem.

  • Our teams implement robust measures to safeguard sensitive patient information and ensure the integrity and confidentiality of data. Our comprehensive security solutions mitigate cybersecurity risks, fostering trust among users and enabling the secure adoption and utilization of SaMD in healthcare environments.

  • We leverage sophisticated AI algorithms and rigorous testing strategies to deliver AI Software as a Medical Device (SaMD) solutions that exceed standards of performance, safety, and functionality. Our approach ensures robustness and effectiveness of your SaMD, bolstering its readiness for market entry and alignment with regulatory stipulations.

FDA regulated software design and development

Any companion software serving a medical or device function is subject to FDA regulation. Like the hardware device components, software must also be rigorously documented throughout all phases of design and development. This helps ensure ease of FDA 510(k) application and De Novo classification request for class I and class II medical devices, and FDA approval for class III devices. Our internal Quality Management System (eQMS) Greenlight Guru helps the team manage the entire medical device software lifecycle.

The client perspective

Brian Howe, Format Health

HTD has met or exceeded all of our high expectations. They are excellent communicators who constantly find new ways to create value. In addition to delivering superb work on time and within budget, they've become trusted advisors on a range of critical issues. We could not be more pleased with our relationship and highly recommend HTD for any healthcare vendor or provider.

Brian Howe

Chief Executive Officer,
Format Health

client work

Next-generation devices

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Ready to transform healthcare?

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