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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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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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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.

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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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Revolutionize SaMD development: Agile meets IEC 62304

Integration of IEC 62304's for medical device software into the Agile development process can be very challenging. It begins from the macro perspective and then breaks down into smaller components