MedDeviceGuide — IVD & Medical Device Knowledge Base
ISO 10993-1:2025: What Changed, Why It Matters, and How to Prepare
Practical guide to ISO 10993-1:2025 changes, including risk-based biological evaluation, the new table framework, exposure duration updates, genotoxicity, and compliance steps.
EU IVDR Classification Rules: The Complete Guide to IVD Risk Classes A–D
Practical guide to IVDR Annex VIII classification rules for IVD Classes A-D, with device examples, software guidance, IVDD-to-IVDR changes, and the 2025 EU simplification proposal.
EU MDR Notified Bodies and Conformity Assessment Guide
Guide to EU MDR Notified Bodies and conformity assessment, including NB selection, routes by device class, audits, timelines, costs, and 2025-2026 regulatory context.
EUDAMED Registration Guide for Medical Device and IVD Manufacturers
Step-by-step EUDAMED registration guide covering SRN actor registration, UDI/device data, Notified Body certificates, market surveillance, May 2026 deadlines, and legacy devices.
FDA Breakthrough Device Designation: Program Guide for 2026
Guide to FDA Breakthrough Device Designation in 2026, including eligibility criteria, Q-Submission application steps, program benefits, timelines, statistics, and pathway strategy.
FDA Medical Device Recalls: Corrections, Removals, and Classification
Guide to FDA medical device recalls under 21 CFR 7, 806, and 810, including voluntary and mandatory recalls, Class I/II/III classification, reporting, strategy, and compliance.
FDA Pre-Submission Guide: Get Feedback Before a Device Submission
Guide to FDA's Q-Submission program for medical devices, including Pre-Subs, Submission Issue Requests, Information Meetings, feedback requests, content, timelines, fees, and meeting strategy.
ISO 13485 Internal Audit Guide: Checklist, Process, and Best Practices
Guide to ISO 13485 internal audits, including Clause 8.2.4 expectations, audit planning, checklists, auditor qualifications, nonconformities, CAPA linkage, and certification readiness.
FDA Medical Device Reporting: Adverse Event Rules Under 21 CFR Part 803
Guide to FDA Medical Device Reporting under 21 CFR Part 803, including reportable events, 30-day and 5-day deadlines, eMDR submissions, MAUDE, and enforcement risk.
Medical Device Change Control: FDA and EU MDR Requirements
Guide to medical device change control for design, process, and regulatory changes, including FDA QMSR, EU MDR significant changes, Notified Body notification, and best practices.
Medical Device Shelf Life and Stability Testing Guide
Plan shelf life and stability testing for medical devices, including ASTM F1980 accelerated aging, real-time studies, sterile barrier testing, packaging validation, and expiration dating.
Medical Device Technical File: EU MDR Documentation Guide
Prepare EU MDR technical documentation for medical devices, including Annex II and III content, FDA DHF comparisons, STED format, ISO 13485 files, and practical assembly steps.
Top Medical Device Consulting Firms: Choose a Regulatory & Quality Partner
Compare medical device consulting firms in 2026 across regulatory affairs, quality systems, clinical strategy, market access, pricing, and selection criteria.
Medical Device Clinical Trials: FDA IDE Requirements Guide
Understand FDA IDE requirements, 21 CFR 812 risk categories, study design, ISO 14155 alignment, submission steps, costs, and clinical trial timelines.
Medical Device Quality Audits: FDA, ISO 13485, EU MDR and MDSAP
Prepare for medical device quality audits, including FDA QMSR inspections, ISO 13485, EU MDR notified body audits, MDSAP, internal audits, findings, and remediation.
Medical Device Industry News and Regulatory Updates 2026
Roundup of 2026 medical device regulatory changes, FDA actions, EU MDR/IVDR milestones, and industry trends, plus what to prepare for in 2027.
Medical Device M&A and Funding: Due Diligence and Valuation Guide
Guide to medical device M&A, venture funding, startup investment, regulatory due diligence, valuation methods, deal structures, and 2026 market trends.
Medical Device Process Validation: IQ, OQ, PQ, and the Complete Implementation Guide
Implement medical device process validation with IQ, OQ, and PQ methods, FDA and GHTF expectations, statistical tools, master plans, and continued process verification.
Medical Device Supply Chain Risk Management and Supplier Quality
Manage medical device supply chain risk with supplier qualification, risk assessment, dual sourcing, quality agreements, FDA and ISO 13485 controls, and resilience planning.
EU MDR PMCF Guide: Plans, Studies, Reports, and Implementation
Guide to PMCF under EU MDR, including PMCF plans, study design, evaluation reports, PMS integration, clinical evaluation updates, and implementation.