Digital Health & AI

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 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.

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.

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 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.

How to develop and implement a Predetermined Change Control Plan (PCCP) for AI-enabled medical devices under FDA's August 2025 final guidance — three mandatory components, submission strategy, real-world examples, and step-by-step implementation roadmap.

A comprehensive guide to IEC 82304-1 health software product safety — how it complements IEC 62304, product requirements, validation, cybersecurity, lifecycle management, regulatory alignment with FDA/EU MDR, and practical implementation for SaMD and health app manufacturers.

Everything medical device manufacturers need to know about Software Bill of Materials — FDA cyber device requirements, NTIA minimum elements, SPDX vs CycloneDX formats, VEX integration, tools, and post-market management strategies.

A data-driven analysis of the AI medical device investment boom — covering the Medtronic/CathWorks deal, Zimmer Biomet/Monogram acquisition, HistoSonics' $2.25B valuation, record FDA AI clearances, and how AI now drives 55% of all health tech funding in 2025-2026.

Complete guide to digital health and AI medical device regulation across MENA — SFDA MDS-G27 guidance on digital health products (SaMD, mHealth, DTx, AI/ML, telemedicine, wearables, VR/AR), UAE EDE AI registration frameworks and National AI Strategy 2031, Turkey TITCK software medical device classification and exclusion list, Israel AMAR software requirements, and practical compliance strategies for each market.

A comprehensive analysis of the surgical robotics M&A and funding landscape in 2025-2026 — from Intuitive's dominance to the rise of challengers like CMR Surgical, Medtronic Hugo, J&J OTTAVA, and Distalmotion, plus the shift from VC-backed pioneers to PE-led consolidation.

The complete guide to South Korea's Digital Medical Products Act — product categories (digital medical devices, digital-convergence pharmaceuticals, digital health-support devices), MFDS classification, approval pathways, AI/ML requirements, cybersecurity obligations, QMS, and labeling requirements.

A complete guide to the regulatory pathway for digital therapeutics — including FDA clearance strategies (510(k), De Novo, PMA), EU MDR classification, Germany's DiGA reimbursement program, approved DTx products, clinical evidence requirements, and what's changing in 2026.

Comprehensive guide to the EU AI Act requirements for AI-enabled medical devices — covering high-risk classification, conformity assessment, the dual compliance model with MDR/IVDR, data governance, transparency, human oversight, and the August 2026 enforcement deadline.

Everything you need to know about using real-world evidence (RWE) and real-world data (RWD) for medical device regulatory submissions in 2026 — including the December 2025 FDA final guidance update, acceptable data sources (EHRs, registries, claims databases), relevance and reliability criteria, premarket and postmarket applications, de-identified data policy change, practical steps for incorporating RWE into your regulatory strategy, and comparison with traditional clinical evidence.

Everything you need to know about marketing medical devices in Germany in 2026 — including EU MDR requirements, BfArM and PEI responsibilities, MPDG national law, German-language labeling mandates, DMIDS and EUDAMED registration, clinical investigation procedures, DiGA digital health pathway, and practical market entry guidance for Europe's largest medical device market.

The complete guide to artificial intelligence and machine learning in medical devices — FDA's AI/ML action plan, predetermined change control plans, SaMD classification, 510(k) and De Novo pathways, EU MDR requirements, and Good Machine Learning Practice.

The complete guide to medical device cybersecurity regulations — FDA Section 524B requirements, SBOM, threat modeling, premarket submissions, post-market vulnerability management, and EU MDR cybersecurity obligations.