Medical Device & IVD Blog
Endotoxin and Pyrogen Testing for Medical Devices: BET Guide
Guide to medical device endotoxin and pyrogen testing, including BET methods, rFC alternatives, ISO 11737-3, USP <85>/<161>, FDA guidance, and device limits.
Switzerland Swissmedic Medical Device Registration Guide (2026)
How to register medical devices in Switzerland under Swissmedic: CH-REP duties, MedDO/IvDO rules, swissdamed deadlines, CE reliance, fees, and PMS obligations.
Wearable Medical Devices: Regulatory Pathway Guide (FDA, EU MDR 2026)
Guide to wearable medical device regulation in the US and EU, including FDA wellness policy, 510(k), De Novo, EU MDR classification and manufacturer compliance strategy.
Batch Records for Medical Devices: BMR, EBR, DHR, and FDA QMSR
Guide to batch manufacturing records, electronic batch records, and DHRs for medical devices, covering 21 CFR 210/211, FDA QMSR, ISO 13485, review workflows, deviations, and inspection readiness.
Bioburden Testing for Medical Devices: Complete ISO 11737-1 Guide
Guide to bioburden testing under ISO 11737-1:2018, covering method validation, recovery efficiency, extraction, enumeration, dose setting, and routine monitoring for medical device sterilization.
Cleanroom Standards for Medical Devices: Complete ISO 14644 Guide
Classify, design, validate, and monitor ISO 14644 cleanrooms for medical devices, including particle limits, environmental monitoring, FDA/EU GMP expectations, and 2025 updates.
Cost of Quality in Medical Devices: Prevention, Appraisal, and Failure Costs
How to calculate and reduce medical device Cost of Quality using prevention, appraisal, internal failure, and external failure categories aligned with ISO 13485 and FDA QMSR.
CSV to CSA Transition: FDA Computer Software Assurance Guide
How to move from CSV to FDA's Computer Software Assurance approach, covering risk-based validation, testing strategy, documentation, and a practical transition roadmap.
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.