MedDeviceGuide — IVD & Medical Device Knowledge Base
FDA Emergency Use Authorization for Medical Devices: Regulatory Pathway
FDA EUA guide for medical devices covering Section 564 authority, CBRN emergency triggers, submission criteria, EUA vs 510(k)/PMA, termination, and active EUAs.
Engineering Change Order (ECO) for Medical Devices: Complete Process Guide
Medical device ECO guide covering ECR-to-ECN workflows, ISO 13485 design change controls, FDA QMSR expectations, risk assessment, regulatory triggers, and approvals.
Equipment Calibration Management for Medical Devices: ISO 13485 Clause 7.6 Complete Guide
Guide to medical device equipment calibration management under ISO 13485 Clause 7.6 and FDA QMSR, covering traceability, schedules, out-of-tolerance handling, records, and software tools.
EU Cyber Resilience Act (CRA) + NIS2: Impact on Medical Device Manufacturers in 2026-2027
Explains how the EU CRA and NIS2 affect medical device companies, including MDR/IVDR exemptions, indirect CRA exposure, supply chain duties, and deadlines.
EU MDR Classification Rules (Annex VIII): Complete Guide to All 22 Rules with 2026 Updates
Walk through all 22 EU MDR Annex VIII classification rules, including invasive, active, software, nanomaterial, and special rules with 2026 guidance.
EU MDR Common Specifications: Article 9, Annex XVI, and 2026 Compliance
Guide to EU MDR Common Specifications under Article 9, including Annex XVI products, IVD common specifications, conformity effects, and timelines through 2028.
EU Declaration of Conformity for Medical Devices: 2026 Template Guide
How to draft an EU MDR Declaration of Conformity under Article 19 and Annex IV, including required content, language rules, legacy devices, and templates.
EU MDR GSPR Annex I: General Safety and Performance Requirements Guide
Guide to demonstrating compliance with EU MDR Annex I GSPR, including all 23 requirements, evidence mapping, standards, cybersecurity, AI, and NB review tips.
EU MDR Harmonised Standards: 2026 List, GSPR Mapping, and Conformity
Guide to EU MDR harmonised standards under Article 8, including the 2026 list, presumption of conformity, GSPR mapping, MDCG guidance, and compliance gaps.
EU MDR Importer & Distributor Obligations: Complete Guide to Articles 13, 14, and 16
Guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16, including registration, labeling, QMS duties, checks, and MDCG guidance.
EU MDR PRRC Guide: Article 15 Responsibilities and 2026 Changes
Guide to the EU MDR Person Responsible for Regulatory Compliance, covering Article 15 qualifications, duties, outsourcing, MDCG guidance, liability, and 2026 changes.
FDA Medical Device Advertising and Promotion Compliance Guide (2026)
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.
FDA Clinical Decision Support Software: Device vs Non-Device Guide
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.
FDA Establishment Registration & Device Listing: Complete Compliance Guide
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.
FDA eSTAR Electronic Submission Template: Complete Guide to 510(k) and De Novo Submissions
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.
FDA Export Certificates for Medical Devices: CFS, CFG, COE Complete Guide
Guide to FDA export certificates for medical devices, including CFG, CFS, COE, CECATS applications, fees, eligibility, common mistakes, and global market access steps.
FDA Inspection Readiness for Medical Devices: Complete Guide to QMSR Inspections in 2026
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.
FDA PCCP Guide for AI/ML Medical Devices
Build FDA-ready Predetermined Change Control Plans for AI/ML devices, including PCCP components, submission strategy, examples, and implementation steps.
FDA QMSR Inspection Preparation: Complete Guide to Compliance Program CP 7382.850
Prepare for FDA QMSR inspections under CP 7382.850 with the six QMS areas, OAFRs, risk-based methods, ISO 13485 alignment, and readiness steps.
GMP vs cGMP for Medical Devices Under FDA QMSR
Understand GMP and cGMP expectations for device manufacturing under FDA QMSR, 21 CFR Part 820, ISO 13485, design controls, production, labeling, and inspections.