Medical Software Compliance Digest

This partnership pairs formal verification expertise with regulatory implementation support to deliver traceable safety evidence for medical...

AI medical interpretation creates new PHI exposure points through real-time capture, transcription, and storage—unlike prior phone-based...

IEC 62304 defines software lifecycle processes to ensure clinical safety, assuming ISO 13485 and ISO 14971.

• Classify early: Assign A/B/C based on...

The FDA's proposed predetermined change control plan (PCCP) lets manufacturers submit an upfront plan for anticipated algorithm changes in AI medical...

The FDA's discussion paper proposes assessing generative AI devices through competency testing modeled on physician training rather than exhaustive...

The FDA's discussion paper examines generative AI device regulation through dual lenses of broad challenges and a novel evaluation proposal.

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• 1,500+ FDA-authorized AI devices rely mainly on 510(k) equivalence, not prospective outcomes data.
• Epic Sepsis Model showed 33% sensitivity and...

Traceability across linked quality processes is critical for ISO 13485 compliance throughout the device lifecycle.

• Demonstrate full workflows: move...

The FDA's proposed predetermined change control plan lets manufacturers of continuously learning AI medical devices submit upfront details on expected...

The MHRA AI Airlock serves as a regulatory sandbox to resolve open questions on AI as a medical device, not as an approval pathway.

Key outcomes for...

AI cardiovascular risk models show promising discrimination yet remain unsuitable for regulatory clearance or clinical use, with external validation...

SBOX delivers identical HIPAA-aligned controls across three deployment models—private cloud, managed private cloud, and VPC—without altering the...

From August 2026, AI-enabled medical devices face simultaneous MDR and EU AI Act high-risk obligations.

• Who is affected: Class IIa+ MDR devices...

AI decision support tools are entering active trials faster than validation frameworks can keep up, creating an evidence latency problem that leaves...

The evolution toward digital pathology has driven creation of the dedicated Software as a Medical Device (SaMD) regulatory category, now intersecting with the In Vitro Diagnostic Medical Devices Regulation.

MDUFA VI emphasizes refinement over major overhaul for FY 2028–2032.

• Pre-submission changes: New $2,000 fee for initial submissions; annual cap at...

Seventy-one percent of U.S. hospitals integrated predictive AI into EHRs by 2024, outrunning both evidence generation and regulatory frameworks.

• A...

The proposed framework outlines a staged translational pathway spanning technical development, prospective validation, clinical deployment, and...

Two early post-QMSR warning letters cite specific ISO 13485:2016 clauses, showing FDA expects traceable risk integration across the quality system.

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• Three-phase design combined readability metrics on 210 outputs, expert review by 15 clinicians, and a 54-patient survey
• Experts scored accuracy...