MedDeviceGuide — IVD & Medical Device Knowledge Base
Humanitarian Device Exemption (HDE): Complete Guide to FDA Rare Disease Device Pathway
Use FDA's HDE pathway for rare disease devices, including HUD designation, probable benefit evidence, HDE applications, profit rules, IRB oversight, QMSR, and post-approval duties.
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.
IEC 82304-1 Health Software Product Safety: Complete Compliance Guide (2026)
Implement IEC 82304-1 for health software product safety, including product requirements, validation, cybersecurity, lifecycle management, IEC 62304 links, and FDA/EU MDR alignment.
ISO 11137 Radiation Sterilization: Gamma, E-Beam, and X-Ray Guide
Guide to ISO 11137 radiation sterilization for medical devices, covering gamma, e-beam, and X-ray methods, dose establishment, materials compatibility, validation, and dose audits.
ISO 13485 Implementation Guide: From Zero to Certification
Step-by-step guide to implementing ISO 13485 from scratch, covering QMS structure, clause requirements, documents, audit stages, costs, timelines, and FDA QMSR alignment.
ISO 14155:2026 Clinical Investigation of Medical Devices: GCP Guide
Guide to ISO 14155:2026 for medical device clinical investigations, covering GCP expectations, risk management, committees, estimands, sponsor duties, adverse events, and post-market studies.
ISO 15223-1 Medical Device Symbols: Complete Labeling and Marking Guide (2026)
Guide to ISO 15223-1 medical device symbols and labeling, covering the 2025 EU REP amendment, MDR/IVDR requirements, symbol validation, categories, and implementation.
ISO 17665 Steam Sterilization Guide for Medical Devices
Guide to ISO 17665 steam sterilization, covering moist heat principles, IQ/OQ/PQ validation, F0 lethality, biological indicators, cycle design, autoclave qualification, and monitoring.
LDT Regulatory Guide: FDA 2024 Rule Vacatur, CLIA Oversight, and Next Steps
Guide to LDT regulation after FDA's 2024 rule was vacated, covering CLIA oversight, enforcement discretion, ACLA litigation, and steps laboratories should take.
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.
PSUR Under EU MDR Article 86: 2026 Periodic Safety Update Report Guide
Prepare an EU MDR Article 86 PSUR with class-based frequency, MDCG 2022-21 structure, EUDAMED submission, PMS data, and benefit-risk analysis.
QA vs QC in Medical Devices: Roles, Responsibilities, and QMSR Impact
Compare QA and QC in medical device manufacturing, including process vs product focus, team roles, tools, organizational structure, and QMSR alignment.
Quality Culture in Medical Devices: Leadership Practices Under FDA QMSR
Build medical device quality culture with leadership practices, ISO 13485 management responsibility, behavioral indicators, audits, and FDA QMSR expectations.
Medical Device Quality Investigation Guide: Complaints, NCRs, and Audit Findings
Conduct medical device complaint, NCR, and audit finding investigations with root cause methods, CAPA, and ISO 13485, FDA 21 CFR 820, and EU MDR alignment.
Quality KPIs and Metrics for Medical Devices: ISO 13485 and QMSR Guide
Build medical device quality KPIs for CAPA effectiveness, first pass yield, complaints, design controls, cost of quality, and ISO 13485 and QMSR alignment.
Medical Device Quality Manual Guide: ISO 13485 Clause 4.2.2 Requirements
Write an ISO 13485:2016 medical device quality manual covering scope, procedures, QMS interactions, exclusions, FDA QMSR considerations, and template structure.
Root Cause Analysis for Medical Devices: RCA Methods, Tools, and CAPA Integration
Guide to medical device root cause analysis, covering 5 Whys, fishbone diagrams, fault tree analysis, Pareto charts, CAPA links, and FDA 483 risks.
SBOM for Medical Devices: FDA Section 524B, EU CRA, and NTIA Guide
Medical device SBOM guide covering FDA cyber device requirements, NTIA minimum elements, SPDX and CycloneDX formats, VEX integration, tooling, and postmarket management.
EU MDR SSCP Guide: Safety and Clinical Performance Summary for Devices
Learn how to prepare, validate, translate, and publish EU MDR SSCPs under Article 32, including MDCG 2019-9 Rev.1, lay summaries, NB review, and EUDAMED.