Digital Health & AI
96 articles
Should You Trust AI in Regulatory Work? A Vendor-Neutral Checklist After DJ Fang's Pilot
A vendor-neutral operational audit for medtech RA and quality teams evaluating AI workflow tools, covering CSV, source provenance, master dossier reuse, and reliance.
Master Protocols and Platform Trials for Medical Devices: The Adoption Gap
Analysis of master protocol, platform, basket, and umbrella trial adoption in medical devices — with ClinicalTrials.gov data showing near-zero device uptake and when the design pays off.
FDA AI-Enabled Medical Device Guidance: Transparency, Labeling & GMLP
Guide to FDA AI medical device rules. Map GMLP, June 2024 transparency, and January 2025 draft guidance to submission and labeling artifacts.
Adaptive AI Medical Devices: Why an FDA PCCP Won't Update Your Model in the EU or Japan
A cross-market analysis of AI medical device change control, comparing the US FDA PCCP, Japan's IDATEN framework, and the EU's MDR and AI Act modification rules.
How Generative AI Now Picks Medical Devices for Hospital Procurement
Discover how Value Analysis Committees and hospital procurement teams use generative AI to source devices, and why off-site evidence footprints dominate AI recommendations.
FDA OTC Hearing Aid Regulation: Product Codes & MAUDE Adverse Events
A comprehensive B2B regulatory guide to the FDA OTC hearing aid framework. Details product codes, 510(k) exemptions, conditions for sale, and MAUDE data.
European Health Data Space (EHDS) Regulation: Guide for Medical Device Manufacturers
How Regulation (EU) 2025/327 applies to medical devices and IVDs. Learn about Article 27 software components, CE marking, 2027-2031 deadlines, and GDPR alignment.
Hologic Global Footprint: Genius 3D Mammography, Genius AI, and IVD Market Access
An FDA regulatory and market access footprint dossier of Hologic, mapping Genius 3D Mammography PMA P080003, Genius AI clearances, and Panther diagnostics.
ResMed Global Regulatory Footprint: AirSense 11, Smart Comfort AI, and Market Access
An FDA regulatory and market access footprint dossier of ResMed, mapping AirSense 11 and Smart Comfort AI clearances, product codes, and market shares.
Saudi SFDA MDS-G27: Digital Health and Wellness Device Regulation
A comprehensive guide to Saudi Arabia's SFDA MDS-G27 (2025) regulation on digital health. Understand the boundary between medical devices and wellness software.
Medical Device Accessibility: ADA, Section 508, and EU Accessibility Act Guide
ADA Title II/III, Section 508, WCAG 2.1 AA, and the EU Accessibility Act applied to medical devices, SaMD, patient apps, and infusion-pump screens — what it means for device design.
Software as a Medical Device (SaMD) Regulation Compared: SFDA, ANVISA, NAFDAC, PPB
Compare how Saudi SFDA MDS-G23, Brazil ANVISA RDC 657/2022, Nigeria NAFDAC and Kenya PPB regulate Software as a Medical Device — definitions, risk classes, and filing routes.
EU AI Act for Medical Devices: August 2028 Deadline and MDR Dual Compliance Strategy
EU AI Act Omnibus extends medical device AI compliance to August 2, 2028. Dual MDR strategy, data governance, human oversight, tech doc integration, and preparation timeline.
EU AI Act High-Risk Classification Guidelines for Medical Device Manufacturers
EU Commission's May 2026 draft Article 6 high-risk AI classification guidelines: two-path system for medical devices, consultation deadline June 23, and compliance deadlines in 2027-2028.
Medical Device Cybersecurity Is Now a Procurement Gate: 2026 Hospital Buying Data
RunSafe's 2026 Index: 56% of hospitals reject devices over cybersecurity, 35% won't buy without an SBOM, and 84% include security in RFPs. What manufacturers must do now.
Medical Device Software Verification vs Validation: FDA and IEC 62304 Requirements
Software verification vs validation for medical devices — FDA expectations, IEC 62304 activities, documentation, traceability, and the design control process.
eDHR for Medical Devices: QMSR, Part 11 & Digital Manufacturing (2026)
eDHR implementation guide for medical device manufacturers: QMSR requirements, 21 CFR Part 11, MES integration, ISO 13485, paper-to-digital migration, and inspection readiness.
RPM Device Regulatory Pathway: FDA, CMS Reimbursement & EU MDR (2026)
RPM device regulation: FDA classification, CMS 2026 CPT codes (99445, 99470), reimbursement rates, SaMD, EU MDR pathway, and commercialization strategy for connected monitoring devices.
Abbott Libre Duo CE Mark: Dual Glucose-Ketone CGM Strategy (2026)
Abbott Libre Duo CE mark analysis covering the first continuous glucose-ketone sensor, dual-analyte regulatory strategy, CGM competition, FDA pathway, and wearable convergence.
EU Digital Product Passport for Medical Devices: ESPR, Batteries, and UDI
Guide to EU Digital Product Passport requirements for medical devices, including ESPR scope, battery passports, UDI/EUDAMED links, standards, and timelines.