United States
287 articles
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.
Direct-to-Consumer Genetic Tests: FDA, FTC, Privacy, Clinical Validity, and Claims Control
Guide to regulatory, privacy, and commercial risks for DTC genetic tests, including FDA oversight, FTC claim substantiation, clinical validity, GINA, state privacy laws, and risk-report claims.
Home-Use and Self-Test IVDs: Pathways, Human Factors, and Labeling
Regulatory guide for home-use and self-test IVDs, covering FDA OTC and CLIA pathways, EU IVDR self-testing, human factors, labeling, specimen errors, and PMS.
ISO 17664 Reprocessing Validation for Reusable Medical Devices
Guide to ISO 17664 reprocessing validation for reusable devices, covering cleaning, disinfection, sterilization, worst-case families, IFU content, FDA expectations, and submission evidence.
IVD Analytical Performance Validation: LoD, LoQ, Precision and Stability
Protocol-level guide to IVD analytical validation, covering LoD, LoQ, precision, interference, cross-reactivity, stability, CLSI methods, and FDA/IVDR evidence.
Nanotechnology in Medical Devices: Regulatory and Risk Assessment Guide
Assess medical devices with nanomaterials, including EU MDR Rule 19, FDA guidance, ISO 10993-22, exposure frameworks, nanotoxicology, sterilization, labeling, and regulatory strategy.
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.
Pre-Filled Syringes and Auto-Injectors: Combination Product Regulatory Strategy
Regulatory strategy for pre-filled syringes and auto-injectors, covering FDA OCP/RFD, ISO 11608, human factors, EU MDR Article 117, QMSR, stability, and lifecycle changes.
Medical Device IFU Reprocessing Instructions: Validated, Audit-Ready Guide
Step-by-step guide to writing validated reprocessing instructions for reusable device IFUs, covering cleaning, sterilization, usability, warnings, and audits.
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.
RUO vs IUO vs IVD Labeling: Research, Investigational, and Diagnostic Boundaries
Practical guide to RUO, IUO, and IVD labeling boundaries, covering intended use, FDA guidance, diagnostic-use triggers, marketing risk, and classification decisions.
Supplier Audit Checklist for Medical Devices: ISO 13485, QMSR, and Critical Suppliers
Use this supplier audit checklist for ISO 13485 and FDA QMSR compliance, covering supplier risk, qualification, audit agendas, quality agreements, CAPA follow-up, and records.
Washer-Disinfector Validation: ISO 15883, A0 and Routine Monitoring
Validate washer-disinfector equipment and cycles under ISO 15883, including IQ/OQ/PQ, A0 thermal disinfection, load configurations and routine monitoring.
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.
CMS-FDA RAPID Coverage Pathway: Fast-Track Medicare Coverage for Breakthrough Devices
Explains the 2026 CMS-FDA RAPID pathway for Breakthrough Devices, including Medicare coverage timing, eligibility, IDE study planning, and manufacturer preparation.
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 Recall Trends 2024-2026: Statistics and Root Causes
Analyze 2024-2026 medical device recall trends, including Class I increases, device failure causes, software defects, FDA alerts, affected units, and risk mitigation.
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.