Digital Health & AI
87 articles
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Guide to FDA's January 2025 draft guidance on AI-enabled device software functions, including TPLC controls, data management, bias mitigation, transparency, and submission content.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.
Medical Device Third-Party Cybersecurity Risk Management Guide
Manage third-party cybersecurity risk for connected medical devices using FDA Section 524B, QMSR and ISO 13485 controls, SBOMs, vendor assessments, and threat modeling.
AR/VR Medical Devices: FDA Pathways, Classification, and 2026 Guide
Guide to AR and VR medical device regulation in 2026, including FDA classification, product codes, 510(k) and De Novo routes, cleared devices, surgical navigation, therapeutic VR, and human factors.
Medical Device Interoperability: HL7, FHIR, and Connected Device Standards in 2026
Learn how HL7 FHIR, IEEE 11073, and DICOM support medical device interoperability, including CMS mandates, FDA expectations, and implementation guidance.
Privacy by Design for Medical Devices: Connected Healthcare Guide
Implement Privacy by Design in connected medical devices, with GDPR, HIPAA, data minimization, consent, anonymization, and 2026 privacy expectations.
Agile vs Waterfall for Medical Device Software: IEC 62304 Audit Evidence
How to choose Agile, Waterfall, or hybrid medical device software development under IEC 62304, with AAMI TIR45 mapping, design controls, and auditor evidence expectations.
Decentralized Clinical Trials for Medical Devices: FDA and Hybrid Models
How to design decentralized and hybrid clinical trials for medical devices, covering FDA guidance, remote visits, digital endpoints, wearable data, eConsent, and implementation planning.
eIFU for Medical Devices: EU MDR, FDA Rules, QR Codes, and Paper IFUs
Guide to electronic IFU rules for medical devices, covering EU Regulation 2025/1234, FDA 21 CFR Part 801, website access, QR codes, paper fallback, IVDR, SaMD, and validation.
ISO 27001 for Medical Device Companies: Information Security Implementation Guide
Learn how medical device companies can implement ISO 27001, align ISMS controls with ISO 13485 and FDA cybersecurity expectations, and plan certification.
SaMD vs SiMD vs Embedded Software: Classification, Documentation, and Regulatory Strategy
Guide to classifying SaMD, SiMD, and embedded medical device software, with IMDRF definitions, IEC 62304 risk classes, FDA and EU MDR pathways, and documentation strategy.