European Union
280 articles
CSRD for Medical Device Companies: Sustainability Reporting Requirements in 2026
Guide to CSRD sustainability reporting for medical device companies, covering scope, ESRS standards, double materiality, Omnibus simplification, timelines, and practical compliance steps.
EU Notified Body Selection and Change for Medical Devices: 2026 MDR Guide
How to select, evaluate, and change Notified Bodies under EU MDR and IVDR — capacity constraints, selection criteria, transfer process, 2026 implementing regulation, and timeline planning.
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.
Clinical Evaluation Report Template: EU MDR CER Structure and Traceability
Use a section-by-section EU MDR CER template covering clinical evaluation plans, literature search, appraisal tables, equivalence, benefit-risk, PMCF links, and evidence traceability.
Coordinated Vulnerability Disclosure for Medical Device Cybersecurity
Practical guide to medical device CVD programs, including PSIRT setup, vulnerability intake, CVSS scoring, SBOM linkage, FDA Section 524B, EU expectations, and customer communication.
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.
Direct-to-Consumer Genetic Tests: FDA, FTC, Privacy, Clinical Validity, and Claims Control
Guide to regulatory, privacy, and commercial risks for DTC genetic tests, including FDA oversight, FTC claim substantiation, clinical validity, GINA, state privacy laws, and risk-report claims.
EU MDR GSPR Checklist Template: Annex I Evidence Matrix for Technical Documentation
Downloadable EU MDR GSPR checklist template for Annex I evidence mapping, applicability, standards, gap analysis, ownership, and remediation tracking.
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.
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.
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.