MedDeviceGuide — IVD & Medical Device Knowledge Base

Guide to EU MDR harmonised standards under Article 8, including the 2026 list, presumption of conformity, GSPR mapping, MDCG guidance, and compliance gaps.

Guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16, including registration, labeling, QMS duties, checks, and MDCG guidance.

Guide to the EU MDR Person Responsible for Regulatory Compliance, covering Article 15 qualifications, duties, outsourcing, MDCG guidance, liability, and 2026 changes.

Guide to FDA medical device advertising and promotion compliance, including 21 CFR Part 801, OPEQ enforcement, off-label claims, social media, FTC oversight, and warning letters.

Guide to FDA clinical decision support software policy, including Section 520(o)(1)(E), non-device CDS criteria, SaMD boundaries, examples, and digital health compliance steps.

Guide to FDA establishment registration and device listing under 21 CFR Part 807, including FURLS/DRLM, FY 2026 fees, who must register, annual renewal, and common violations.

Guide to FDA eSTAR electronic submission templates for 510(k) and De Novo, including mandatory use, template structure, completeness checks, submission methods, and common mistakes.

Guide to FDA export certificates for medical devices, including CFG, CFS, COE, CECATS applications, fees, eligibility, common mistakes, and global market access steps.

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.

Build FDA-ready Predetermined Change Control Plans for AI/ML devices, including PCCP components, submission strategy, examples, and implementation steps.

Prepare for FDA QMSR inspections under CP 7382.850 with the six QMS areas, OAFRs, risk-based methods, ISO 13485 alignment, and readiness steps.

Understand GMP and cGMP expectations for device manufacturing under FDA QMSR, 21 CFR Part 820, ISO 13485, design controls, production, labeling, and inspections.

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.

Validate vaporized hydrogen peroxide sterilization under ISO 22441:2022, including FDA recognition, process parameters, material compatibility, validation protocols, and regulatory strategy.

Meet IEC 60601-1-2 EMC requirements for medical electrical equipment, including emissions, immunity, Edition 4.1, risk management, test plans, environments, and submissions.

Implement IEC 82304-1 for health software product safety, including product requirements, validation, cybersecurity, lifecycle management, IEC 62304 links, and FDA/EU MDR alignment.

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.

Step-by-step guide to implementing ISO 13485 from scratch, covering QMS structure, clause requirements, documents, audit stages, costs, timelines, and FDA QMSR alignment.

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.

Guide to ISO 15223-1 medical device symbols and labeling, covering the 2025 EU REP amendment, MDR/IVDR requirements, symbol validation, categories, and implementation.