Standards & Testing
71 articles
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.
Ultrasound Probe Repair vs Replace: An HTM Decision Framework With MAUDE Evidence
A detailed guide for HTM and biomedical engineering teams to evaluate whether to repair or replace diagnostic ultrasound transducers based on failure modes, safety risks, and compliance.
Acceptance Sampling Plans for Medical Devices: AQL, Z1.4 & ISO 2859
How to build statistically valid medical device sampling plans under 21 CFR 820.250 / ISO 13485: AQL, ANSI/ASQ Z1.4, ISO 2859-1 switching rules, c=0 plans, and OC curves.
Medical Device Reliability Testing: HALT, HASS, ALT & MTBF
A practical guide to medical device reliability testing: HALT vs HASS vs accelerated life testing, Weibull and MTBF, Arrhenius acceleration, and where it fits in ISO 13485 design V&V.
IVD Calibrator Traceability: ISO 17511, EU IVDR, and JCTLM Guide
Metrological traceability for IVD calibrators and control materials under ISO 17511:2020 and EU IVDR Annex I Section 9.3, covering calibration hierarchies, JCTLM resources, and common pitfalls.
ISO 19011:2026: What the Updated Audit Standard Means for Medical Device Manufacturers
ISO 19011:2026 embeds hybrid auditing, digital evidence management, and updated auditor competence across the audit lifecycle — what ISO 13485 and QMSR programs need to update.
NAMs for Medical Device Biocompatibility: FDA, EU & ISO 10993 Guide (2026)
NAMs for medical device biocompatibility: FDA roadmap, EU phase-out plan, ISO 10993-5/-10/-23 in vitro alternatives, chemical characterization, and regulatory strategy.
Auto-Injector Critical-Task Matrix for Human Factors Validation
Guide to auto-injector critical-task matrices for human factors validation, including URRA inputs, dose confirmation, hold time, misfire recovery, training decay, and FDA evidence expectations.
FDA ASCA Test Report Acceptance Package for 510(k) and De Novo
Step-by-step guide to ASCA evidence packages for 510(k) and De Novo submissions, including summary test reports, declarations, lab accreditation, scope matching, and FDA questions.
FDA Third Party Review Program: 510(k) Due Diligence Checklist
Evaluate whether 3P510k review fits your device, with checks for product code eligibility, Accredited Person conflicts, eSTAR fit, timing, and risk.
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.
GCP for Medical Device Clinical Trials: ISO 14155 and ICH E6(R3) in 2026
Apply Good Clinical Practice to medical device trials under ISO 14155:2026 and ICH E6(R3), with sponsor duties, consent, safety reporting, and audit readiness.
Cleaning Validation for Reusable Surgical Instruments: Soil, Residue, and Worst Case
Build cleaning validation protocols for reusable surgical instruments, covering test soils, residue endpoints, worst-case devices, ST98 criteria, sampling, and reports.
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.
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.
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.
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.
ISO 17025 Test Laboratory Selection for Medical Devices: Complete Guide
Guide to selecting ISO 17025 accredited laboratories for medical device biocompatibility, EMC, safety, and sterilization testing, including FDA ASCA scope checks and cost factors.