United States
146 articles
FDA Establishment Registration & Device Listing: Complete Compliance Guide
Comprehensive guide to FDA medical device establishment registration and device listing under 21 CFR Part 807 — FURLS/DRLM system walkthrough, FY 2026 fees ($11,423), who must register, annual renewal process, common violations, and step-by-step instructions.
FDA eSTAR Electronic Submission Template: Complete Guide to 510(k) and De Novo Submissions
Comprehensive guide to the FDA eSTAR electronic submission template for 510(k) and De Novo submissions — mandatory requirements since October 2023, template structure, section-by-section walkthrough, completeness verification, submission methods, and common mistakes to avoid.
FDA Export Certificates for Medical Devices: CFS, CFG, COE Complete Guide
Comprehensive guide to FDA export certificates for medical devices — Certificate to Foreign Government (CFG), Certificate of Exportability (COE), CECATS application process, fees, eligibility criteria, common mistakes, and step-by-step instructions for global market access.
FDA Inspection Readiness for Medical Devices: Complete Guide to QMSR Inspections in 2026
How to prepare for FDA medical device inspections under the new QMSR framework (CP 7382.850) — inspection types, the six QMS areas, common 483 observations, and a step-by-step readiness checklist.
FDA Predetermined Change Control Plans (PCCPs) for AI/ML Medical Devices: Complete Implementation Guide
How to develop and implement a Predetermined Change Control Plan (PCCP) for AI-enabled medical devices under FDA's August 2025 final guidance — three mandatory components, submission strategy, real-world examples, and step-by-step implementation roadmap.
FDA QMSR Inspection Preparation: Complete Guide to Compliance Program CP 7382.850
How to prepare for FDA medical device inspections under the new Compliance Program CP 7382.850 — six QMS areas, four OAFRs, risk-based inspection methodology, ISO 13485 alignment, and step-by-step readiness checklist.
GMP vs cGMP for Medical Devices: Complete Guide to Current Good Manufacturing Practice Under FDA QMSR (21 CFR 820)
Understand the difference between GMP and cGMP for medical device manufacturing. Covers FDA QMSR (effective Feb 2026), 21 CFR Part 820, ISO 13485:2016 harmonization, cGMP requirements for design controls, production, packaging, labeling, and FDA inspection readiness.
Humanitarian Device Exemption (HDE): Complete Guide to FDA Rare Disease Device Pathway
Comprehensive guide to the FDA Humanitarian Device Exemption (HDE) pathway for rare disease medical devices — HUD designation process, HDE application requirements, probable benefit standard, profit restrictions, IRB oversight, post-approval obligations, QMSR implications, and step-by-step instructions.
Hydrogen Peroxide Sterilization (ISO 22441): Complete VHP Guide for Medical Devices
How to validate and implement vaporized hydrogen peroxide (VHP) sterilization under ISO 22441:2022 — FDA Established Category A recognition, process parameters, validation protocol, material compatibility, and regulatory pathway for medical device manufacturers.
IEC 82304-1 Health Software Product Safety: Complete Compliance Guide (2026)
A comprehensive guide to IEC 82304-1 health software product safety — how it complements IEC 62304, product requirements, validation, cybersecurity, lifecycle management, regulatory alignment with FDA/EU MDR, and practical implementation for SaMD and health app manufacturers.
ISO 13485:2016 Implementation Guide: Step-by-Step from Zero to Certification — QMS Structure, Clause-by-Clause Requirements, Cost, Timeline, and FDA QMSR Alignment
Complete step-by-step guide to implementing ISO 13485:2016 from scratch. Covers all 8 clauses, documentation hierarchy, certification process (Stage 1 and Stage 2 audits), costs ($5K-$60K+), timeline (6-24 months), notified body selection, and alignment with FDA QMSR effective February 2026.
ISO 15223-1 Medical Device Symbols: Complete Labeling and Marking Guide (2026)
A comprehensive guide to ISO 15223-1:2021 medical device labeling symbols — the 2025 Amendment 1 EU REP change, complete symbol reference by category, MDR/IVDR compliance requirements, symbol validation per ISO 15223-2, and practical implementation for manufacturers.
Laboratory Developed Tests (LDTs) Regulatory Guide: The 2024 Rule, Court Vacatur, and What Comes Next
Complete guide to laboratory developed test regulation in 2026 — FDA's vacated 2024 final rule, the ACLA court decision, current CLIA oversight, enforcement discretion status, and what laboratories must do now.
Management Review for Medical Devices: ISO 13485 & QMSR Compliance Guide
How to conduct management reviews for medical device companies per ISO 13485 Clause 5.6 and FDA QMSR — required inputs, outputs, frequency, documentation, and common audit findings.
QA vs QC in Medical Devices: Complete Comparison — Roles, Responsibilities, Organizational Structure & QMSR 2026 Impact
Quality Assurance vs. Quality Control in medical device manufacturing — proactive vs. reactive, process vs. product, responsibilities, tools, org structure, and how QMSR 2026 changes the landscape. Includes FDA 21 CFR 820 and ISO 13485 alignment.
Quality Culture in Medical Device Manufacturing: Building Leadership-Driven Quality Under FDA QMSR
How to build and sustain a quality culture in medical device organizations — FDA QMSR Comment 27 expectations, ISO 13485 Clause 5 management responsibility, behavioral indicators, leadership practices, audit methods, and a practical framework for cultural transformation.
Quality Investigation for Medical Devices: Complaint, NCR, and Audit Finding Investigation Complete Guide
How to conduct quality investigations for medical devices — complaint handling, nonconformance investigation, audit finding root cause analysis, investigation methods, CAPA integration, and regulatory requirements under ISO 13485:2016, FDA 21 CFR 820, and EU MDR.
Quality KPIs and Metrics for Medical Devices: Complete Framework + ISO 13485 & QMSR 2026 Alignment
How to build a quality KPI framework for medical device companies — CAPA effectiveness, first pass yield, complaint rates, design control metrics, and cost of quality. Fully aligned with ISO 13485:2016 and FDA QMSR 2026 requirements.
Root Cause Analysis for Medical Devices: RCA Methods, Tools, and CAPA Integration
Complete guide to root cause analysis for medical device companies — 5 Whys, fishbone diagrams, fault tree analysis, Pareto charts, CAPA integration, and common mistakes that lead to FDA 483 observations.
SBOM for Medical Devices: Complete Guide to FDA Section 524B, EU CRA & NTIA Compliance (2026)
Everything medical device manufacturers need to know about Software Bill of Materials — FDA cyber device requirements, NTIA minimum elements, SPDX vs CycloneDX formats, VEX integration, tools, and post-market management strategies.