Compliance & Security
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HIPAA Compliant App Development: Technical Requirements and Developer Checklist (2026)
Build HIPAA-compliant healthcare apps in 2026 with updated technical requirements, security measures, and a practical developer checklist to avoid breaches, fines, and…
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What is Software as a Medical Device (SaMD) : Definition, Classification, and Regulatory Pathways
Software as a Medical Device (SaMD) is software that performs a medical function without hardware. Learn how SaMD is classified, regulated, and…
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Step-by-Step: Navigating the ISO 13485 Certification Process
Learn the ISO 13485 certification process for medical device companies, key steps, documentation, and compliance best practices aligned with global standards.
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What Is IEC 62304 Compliance and Why It Matters for Medical Software
Learn what IEC 62304 requires, how to classify software safety, and build compliant medical software aligned with ISO 13485 and ISO 14971…
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5 Phases of Medical Device Software Development: Complete Guide to Build a Safe Software
Learn the 5 key phases of medical device software development and how IEC 62304 and FDA frameworks help teams build safer, compliant…
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Risk Management in Medical Device Development: What Every Startup Should Know
A guide to risk management in medical device development. Learn how startups can ensure safety, compliance, and ISO 14971 alignment from design…