Regulatory

How medical device regulatory affairs teams are using generative AI in 2026 — drafting submissions, clinical evaluation, literature review, regulatory intelligence, and quality system compliance. Covers FDA guidance on AI in submissions, GxP requirements, governance frameworks, and practical implementation strategies.

Complete guide to environmental regulations for medical devices — EU RoHS restricted substances and exemptions, REACH SVHC obligations and SCIP database, WEEE producer responsibilities, global RoHS adoption in China/Korea/Saudi Arabia, and manufacturer compliance strategies in 2026.

Complete guide to IoMT (Internet of Medical Things) regulatory requirements — FDA cybersecurity mandates for connected devices, SBOM requirements under Section 524B, EU MDR compliance for IoMT, market size, risk classification, and manufacturer obligations in 2026.

The definitive medical device glossary with 100+ acronyms and terms — FDA pathways (510k, PMA, De Novo), EU MDR concepts, quality systems (ISO 13485, CAPA, DHF), clinical evidence, standards, and international regulatory abbreviations explained.

A comprehensive guide to Health Technology Assessment (HTA) for medical devices — EU HTA Regulation 2026, NICE evaluations, Joint Clinical Assessments, economic modeling, evidence requirements, and strategies for securing reimbursement and market access globally.

How cloud-based medical devices and SaaS health platforms are regulated in the US and EU — FDA and EU MDR classification of cloud-connected devices, SaMD vs SiMD distinction for cloud software, IEC 62304 Edition 2 lifecycle requirements, cybersecurity (SPDF, SBOM, IEC 81001-5-1), FDA CSA guidance for QMS cloud tools, EU Cyber Resilience Act impact, data integrity and validation challenges, and practical compliance strategies for manufacturers.

Complete guide to HIPAA compliance for medical device manufacturers — when HIPAA applies to devices, the 2026 Security Rule NPRM changes (mandatory encryption, MFA, network segmentation, 24-hour incident notification), business associate agreements for IoMT, FDA cybersecurity overlap, risk assessment frameworks, and step-by-step compliance strategies for connected medical devices.

Complete regulatory guide to mobile medical apps in 2026 — FDA Policy for Device Software Functions, when mobile apps are regulated as medical devices vs wellness products, the 2026 General Wellness and CDS guidance updates, EU MDR classification under Rule 11, mobile-specific cybersecurity and privacy requirements, app store compliance, and step-by-step classification strategies for mobile health developers.

How to register and sell medical devices in Switzerland under Swissmedic — CH-REP requirements, MedDO/IvDO framework, swissdamed registration deadlines (July 2026), CE marking reliance, classification, fees, and post-market obligations after the EU MRA lapse.

How wearable medical devices are regulated in the US and EU — FDA 2026 general wellness guidance, wellness vs. medical device classification, 510(k) and De Novo pathways for smartwatches and CGMs, EU MDR classification, market size data, key cleared devices, and compliance strategy for manufacturers.

Comprehensive guide to the FDA Emergency Use Authorization (EUA) pathway for medical devices under Section 564 of the FD&C Act — legal basis, CBRN emergency triggers, statutory criteria, submission process, EUA vs 510(k)/PMA comparison, post-COVID transition framework, and current active EUAs.

Complete guide to how the EU Cyber Resilience Act (CRA) and NIS2 Directive affect medical device manufacturers — including the MDR/IVDR exemption, indirect CRA impact scenarios, NIS2 supply chain obligations, MDCG cybersecurity guidance, timelines, penalties, and compliance strategies.

Deep walkthrough of all 22 EU MDR classification rules in Annex VIII — non-invasive, invasive, active, and special rules — with MDD-to-MDR changes, software and nanomaterial up-classification, MDCG 2021-24 guidance, and practical strategies for correct device classification.

Comprehensive guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16 — including EUDAMED registration, labeling requirements, QMS obligations, verification checklists, and the MDCG 2021-27 Q&A guidance for economic operators.

Everything about the Person Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15 — qualification pathways, responsibilities, small enterprise outsourcing rules, MDCG 2019-7 guidance, the 2025 simplification package removing rigid qualification thresholds, liability protections, EUDAMED registration, and practical implementation strategies.

Complete guide to FDA medical device advertising and promotion regulations — 21 CFR Part 801 labeling requirements, OPEQ enforcement, off-label promotion rules, social media compliance, FTC oversight, warning letters, and practical strategies for compliant promotional claims.

Complete guide to FDA's January 2026 Clinical Decision Support software guidance — the four statutory criteria for non-device CDS exclusion under Section 520(o)(1)(E), device vs non-device examples, SaMD boundary decisions, enforcement discretion positions, and practical compliance strategies for digital health companies.

Comprehensive guide to FDA medical device establishment registration and device listing under 21 CFR Part 807 — FURLS/DRLM system walkthrough, FY 2026 fees ($11,423), who must register, annual renewal process, common violations, and step-by-step instructions.

Comprehensive guide to the FDA eSTAR electronic submission template for 510(k) and De Novo submissions — mandatory requirements since October 2023, template structure, section-by-section walkthrough, completeness verification, submission methods, and common mistakes to avoid.

Comprehensive guide to FDA export certificates for medical devices — Certificate to Foreign Government (CFG), Certificate of Exportability (COE), CECATS application process, fees, eligibility criteria, common mistakes, and step-by-step instructions for global market access.