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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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Exploring the role of human factors in healthcare: primary care examples

Applied with the input of clinicians, staff, patients, and other stakeholders, human factors can guide research, policy, technology development, and system implementation to improve the efficiency of primary care

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2024’s most impactful digital health trends in MedTech

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AI Solutions: A deep dive into age tech

AI solutions impact on care for older adults isn’t limited to monitoring systems. Age tech branches out into various tools designed to uplift the quality of the 65+ community.

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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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Cybersecurity best practices for Software as Medical Device (SaMD)

Learn about the cybersecurity concerns that healthcare companies should take into account when developing Software as a Medical Device and best practices to cope.