Standards & Testing
58 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.
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.
ASTM D4169 Transportation Validation for Medical Device Packaging
Guide to ASTM D4169 packaging validation, including distribution cycles, assurance levels, drop, compression and vibration tests, ISO 11607 links, sample size, and acceptance criteria.
Fault Tree Analysis for Medical Device Risk Management: FTA vs FMEA
Guide to Fault Tree Analysis under ISO 14971, including FTA vs FMEA, AND/OR gates, probability calculations, examples, and when top-down risk analysis works best.
Sample Size Calculation for Medical Device Clinical Investigations: Methods and Examples
Practical guide to sample size justification for device clinical investigations, covering ISO 14155, EU MDR Annex XV, FDA IDE expectations, common study designs, and worked examples.
Statistical Analysis Plan for Medical Device Trials: SAP Endpoints and Estimands
Develop a medical device SAP covering endpoints, estimands, analysis populations, missing data, sensitivity analyses, multiplicity, timing, and FDA/EU MDR expectations.
IEC 62133 Battery Safety for Medical Devices: Testing and Compliance
Meet IEC 62133 battery safety requirements for medical devices, including testing, FDA and EU MDR expectations, UN 38.3 transport, battery management, and risk controls.
Wireless & RF Regulatory Compliance for Medical Devices: FCC, RED, and Global Requirements
Guide to wireless and RF compliance for connected medical devices, including FCC authorization, EU RED, coexistence testing, cybersecurity and global market access.
Endotoxin and Pyrogen Testing for Medical Devices: BET Guide
Guide to medical device endotoxin and pyrogen testing, including BET methods, rFC alternatives, ISO 11737-3, USP <85>/<161>, FDA guidance, and device limits.
Bioburden Testing for Medical Devices: Complete ISO 11737-1 Guide
Guide to bioburden testing under ISO 11737-1:2018, covering method validation, recovery efficiency, extraction, enumeration, dose setting, and routine monitoring for medical device sterilization.
Cleanroom Standards for Medical Devices: Complete ISO 14644 Guide
Classify, design, validate, and monitor ISO 14644 cleanrooms for medical devices, including particle limits, environmental monitoring, FDA/EU GMP expectations, and 2025 updates.
EU MDR Common Specifications: Article 9, Annex XVI, and 2026 Compliance
Guide to EU MDR Common Specifications under Article 9, including Annex XVI products, IVD common specifications, conformity effects, and timelines through 2028.
EU MDR Harmonised Standards: 2026 List, GSPR Mapping, and Conformity
Guide to EU MDR harmonised standards under Article 8, including the 2026 list, presumption of conformity, GSPR mapping, MDCG guidance, and compliance gaps.
Hydrogen Peroxide Sterilization (ISO 22441): Complete VHP Guide for Medical Devices
Validate vaporized hydrogen peroxide sterilization under ISO 22441:2022, including FDA recognition, process parameters, material compatibility, validation protocols, and regulatory strategy.
IEC 60601-1-2 EMC Testing for Medical Devices
Meet IEC 60601-1-2 EMC requirements for medical electrical equipment, including emissions, immunity, Edition 4.1, risk management, test plans, environments, and submissions.