European Union

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.

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.

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.

Classify, design, validate, and monitor ISO 14644 cleanrooms for medical devices, including particle limits, environmental monitoring, FDA/EU GMP expectations, and 2025 updates.

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.

Medical device ECO guide covering ECR-to-ECN workflows, ISO 13485 design change controls, FDA QMSR expectations, risk assessment, regulatory triggers, and approvals.

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.

Explains how the EU CRA and NIS2 affect medical device companies, including MDR/IVDR exemptions, indirect CRA exposure, supply chain duties, and deadlines.

Walk through all 22 EU MDR Annex VIII classification rules, including invasive, active, software, nanomaterial, and special rules with 2026 guidance.

Guide to EU MDR Common Specifications under Article 9, including Annex XVI products, IVD common specifications, conformity effects, and timelines through 2028.

How to draft an EU MDR Declaration of Conformity under Article 19 and Annex IV, including required content, language rules, legacy devices, and templates.

Guide to demonstrating compliance with EU MDR Annex I GSPR, including all 23 requirements, evidence mapping, standards, cybersecurity, AI, and NB review tips.

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.

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

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

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

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