MedDeviceGuide — IVD & Medical Device Knowledge Base
EUDAMED Registration Mistakes: 10 Errors to Fix Before May 28, 2026
Learn the 10 most common EUDAMED registration mistakes before the May 28, 2026 mandate, including data, UDI, actor, certificate, and workflow errors, plus fixes.
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.
Kenya Medical Device Registration Guide: PPB Process, Fees and Requirements
Register medical devices in Kenya through the PPB, covering Class A-D classification, evaluation routes, reliance pathways, local representative duties, import permits, QMS audits, and surveillance.
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.
PMCF Plan Template: How to Structure Objectives, Methods, Endpoints, Timeline, and Reports
Use this EU MDR PMCF plan template to define objectives, methods, endpoints, timelines, reports, PMS integration, and MDCG 2020-7 traceability.
PMDA eCTD v4.0 for Medical Devices: Complete Transition Guide After the April 2026 Mandate
Japan's PMDA made eCTD v4.0 mandatory on April 1, 2026. Learn what changed, Module 1 expectations, device submission issues, and compliance steps.
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.
EU MDR Well-Established Technologies: Expanded WET Device List 2026
Guide to the 2026 EU MDR Well-Established Technology delegated acts, expanded device lists, clinical investigation exemptions, conformity assessment changes, and manufacturer steps.
Health Canada Medical Device Regulation Reform 2026
Understand Health Canada's 2026 device reforms, including Terms and Conditions powers, AI/ML guidance, REP, IMDRF ToC, significant changes, and market access actions.
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.