Medical Software Compliance Digest

FDA guidance merges traditional QMS requirements with AI-specific adaptations for data lifecycle, bias risks, and model drift.

• QMS adaptations:...

The January 2026 FDA CDS guidance narrows device oversight via enforcement discretion for single-recommendation tools.

• EHR developers gain...

GE HealthCare introduced MIM Anyware™, a zero-footprint web platform delivering system-controlled access to imaging data without local software...

Small practices must maintain a complete, documented HIPAA program across Privacy, Security, and Breach Notification rules, with current risk...

NIH is prioritizing rigorous validation of digital health tools, wearables, and AI algorithms for real-world clinical utility and bias reduction.

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An Engineering Change Request starts formal change management by documenting issues and triggering impact assessment before any modification.

• Core...

A clear regulatory plan prevents delays and cuts long-term costs for SaMD and device startups.

• Define intended purpose in writing early, as...

Healthcare faces zero tolerance for downtime as data from EHRs, imaging, and AI diagnostics surges, while ransomware targets critical systems.

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• Post-COVID regulatory gains: Agencies developed established review pathways for home-use devices while upholding safety standards.
• Market...

Medical device IFUs are regulated risk controls, not optional docs, yet makers routinely treat them as afterthoughts.

• Late-stage IFU work after...

Two frameworks converge on practical AI risk management for medical devices.

• Hazard mapping: Expand FMEA to capture model drift, edge cases, and...

The EU AI Act introduces specific human oversight duties for clinical decision-support systems that could reshape shared decision-making.

• Human...

Agentic AI in clinical trials must be evaluated as regulated operating cost transformation, not a simple software purchase.

• Platform layer shifts...

Design controls under ISO 13485 and FDA 21 CFR 820.30 apply to SaMD, requiring eight documented stages from planning through changes plus a...

Hello and welcome! I'm your Medical Software Compliance Digest curator, here to keep you informed on regulation, safety, and validation of biomedical...