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3 Critical Steps for Efficient Medical Device Software Development

In the evolving landscape of health technology, the role of software in medical devices has never been more crucial. From enhancing device functionality to ensuring user safety, the stakes are high.

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Achieving ISO 13485: HTD’s proven audit checklist

Embarking on the ISO 13485 certification journey involves navigating through a series of critical steps, each requiring detailed attention and rigorous preparation. We share our ISO 13485 audit checklist to help other organizations.

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What happens when FDA QSR harmonizes with ISO 13485?

It is a big moment in the long-anticipated harmonization of the FDA QSR and ISO 13485 standards. FDA's decision to harmonize its QSR with ISO 13485 comes from a desire to streamline regulatory requirements..

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2024’s most impactful digital health trends in MedTech

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10 principles for designing patient-centric UX for healthcare

Guidelines and best practices for digital health teams building patient-facing experiences.

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How to get ISO 13485 certification? 10 most frequently asked questions

Achieving ISO 13485 Certification Offers Many Benefits to Organizations in the Medical Device Field. 10 FAQs on How To Get ISO 13485 - Answered

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Tips for applying Human Factors and Usability Engineering to Software as a Medical Device (SaMD)

Human factors and usability engineering are key in designing medical software. 8 essential tips for human factors and usability engineering applied in mobile app for patients with tremors

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Guidelines for risk management with ISO 14791 in SaMD development

As the field of SaMD continues to evolve, so too will the approaches to risk management. ISO 14971 promotes the safety and efficacy of SaMD

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Let’s disco! – HTD Health’s approach to product discovery

Learn how HTD approaches product strategy and discovery work with new clients.

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Artificial Intelligence

Plan, implement, and analyze cutting-edge AI and ML technologies that enhance patient care, optimize operations, and drive innovation.