Digital Health & AI
96 articles
FDA Real-Time Clinical Trials Pilot for Medical Devices
What device sponsors need to know about FDA's 2026 real-time clinical trials pilot, AI-enabled monitoring, Paradigm Health, and participation readiness.
EU AI Act and MDR Single Evidence Matrix for AI Medical Devices
Guide to building one evidence matrix for AI medical devices under EU MDR and the EU AI Act, mapping Annex II/III files, ISO 14971 risks, PMS/PMCF, cybersecurity, data governance, and QMS evidence.
FDA AI-Enabled Device Predicate Mining for 510(k) and De Novo
Method for mining FDA AI-enabled device and 510(k) databases to identify predicates, compare technology, avoid weak arguments, and build a defensible predicate matrix.
FDA Cybersecurity Unresolved Anomalies Table for Premarket Submissions
Guide to building an FDA unresolved software anomalies table for cybersecurity submissions, including CVSS, exploitability, clinical impact, controls, SBOM links, VEX status, and labeling.
IEC 62304 Edition 2: 2026 Software Lifecycle Changes for Devices
Prepare for IEC 62304 Edition 2 with process rigor levels, broader health software scope, AI/ML lifecycle provisions, cybersecurity integration, and compliance timelines.
NGS Bioinformatics Pipeline Change Control: Documentation and Revalidation Guide
Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.
PCCP Drift Monitoring for AI Imaging Devices: Thresholds and Retraining Triggers
Build FDA PCCP drift monitoring protocols for AI imaging devices, including dataset shift, scanner drift, thresholds, cadence, retraining triggers, and submission boundaries.
SBOM-to-VEX Vulnerability Triage Workflow for Medical Device PSIRTs
PSIRT playbook for medical device SBOM-to-VEX triage, covering CVE intake, component matching, exploitability analysis, VEX rationale, severity scoring, CAPA, field action, and communications.
Special 510(k) for Software and Cybersecurity Changes: Decision Tree and Evidence Package
Decision tree for when a software or cybersecurity update can use Special 510(k) vs Traditional 510(k) — risk analysis, V&V summary, FDA guidance, and evidence package requirements.
FDA Cybersecurity Premarket Deficiencies: 12 Rejection Reasons
Guide to 12 common FDA cybersecurity premarket deficiencies in 2026, including SBOM, threat modeling, risk assessment, Section 524B, guidance alignment, and practical fixes.
FDA AI-Enabled Device Software Guidance: TPLC Draft Guide
Guide to FDA's January 2025 draft guidance on AI-enabled device software functions, including TPLC controls, data management, bias mitigation, transparency, and submission content.
Medical Device Regulatory Sandboxes: MHRA AI Airlock and FDA TEMPO
Guide to medical device regulatory sandboxes, including MHRA AI Airlock, FDA TEMPO for digital health, EU proposals, eligibility, participation, and market access benefits.
Best Regulatory Intelligence Software for Medical Devices 2026
Independent comparison of regulatory intelligence software for medical device and IVD teams, covering RegDesk, IQVIA, Cortellis, Obsidian, Basil Systems, ArisGlobal, Freyr, and Veeva.
Digital Twins and Synthetic Data in Medical Device Validation
Practical guide to digital twins, synthetic data, and computational modeling in medical device submissions, covering FDA credibility guidance, ASME V&V 40, validation limits, and documentation.
NGS Diagnostic Devices Regulatory Guide: FDA, IVDR, CDx, and Bioinformatics
Regulatory strategy for NGS IVD devices, covering FDA pathways, EU IVDR classification, companion diagnostics, bioinformatics validation, and postmarket controls.
Robotic Surgery Devices: FDA and EU MDR Regulatory Pathway Guide
Regulatory strategy guide for surgical robots, covering FDA pathways, EU MDR expectations, autonomy levels, software controls, human factors, and clinical evidence.
Health Canada Medical Device Regulation Reform 2026
Understand Health Canada's 2026 device reforms, including Terms and Conditions powers, AI/ML guidance, REP, IMDRF ToC, significant changes, and market access actions.
Medical Device Penetration Testing and Vulnerability Assessment
See how penetration testing, vulnerability scanning, and fuzz testing support FDA and EU MDR cybersecurity evidence for connected medical device submissions.
FDA Cybersecurity Guidance QMSR Update 2026: What Must Change
Guide to FDA's February 2026 premarket cybersecurity guidance update for QMSR and ISO 13485 alignment, including what changed, what stayed, mapping, and connected device steps.
FDA General Wellness Policy for Wearables: 2026 Non-Device Guide
Guide to FDA's 2026 General Wellness policy for wearable devices, including non-regulated wellness criteria, physiologic parameter examples, claim boundaries, and compliance steps.