Digital Health & AI

Practical GDPR guide for device and IVD manufacturers, covering health data, DPIAs, DPO duties, lawful bases, transfers, EU MDR, IVDR, and AI Act overlap.

Use generative AI in device regulatory work with governance for submissions, literature review, intelligence, clinical evaluation, GxP controls, and compliance risks.

Guide to managing SOUP under IEC 62304, covering identification, risk assessment, safety classification, documentation, open-source controls, and post-market monitoring.

Guide to IoMT regulatory compliance for connected medical devices, covering FDA cybersecurity, SBOM expectations, EU MDR obligations, risk classification, and market access.

Guide to wireless and RF compliance for connected medical devices, including FCC authorization, EU RED, coexistence testing, cybersecurity and global market access.

Guide to FDA and EU MDR regulation of cloud-based medical devices and SaaS health platforms, covering SaMD, SiMD, IEC 62304, cybersecurity, CSA, CRA, and validation.

Manage HIPAA compliance for connected device companies, including applicability, 2026 Security Rule proposals, encryption, MFA, BAAs, IoMT risks, and FDA cybersecurity overlap.

Classify mobile medical apps under FDA and EU MDR rules, including device software functions, wellness exclusions, CDS updates, Rule 11, cybersecurity, privacy, app stores, and 2026 strategy.

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.

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

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.

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.

Build FDA-ready Predetermined Change Control Plans for AI/ML devices, including PCCP components, submission strategy, examples, and implementation steps.

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

Medical device SBOM guide covering FDA cyber device requirements, NTIA minimum elements, SPDX and CycloneDX formats, VEX integration, tooling, and postmarket management.

Data-driven look at AI medical device funding and acquisitions in 2026, including Medtronic/CathWorks, Zimmer/Monogram, HistoSonics, FDA AI clearances, and health tech investment trends.

Guide to digital health and AI medical device regulation in MENA, covering Saudi SFDA, UAE EDE, Turkey TITCK, Israel AMAR, SaMD, mHealth, DTx, and compliance strategy.

Analysis of surgical robotics M&A funding in 2025-2026, covering Intuitive, CMR Surgical, Medtronic Hugo, J&J OTTAVA, Distalmotion, VC, and PE consolidation.

Guide to South Korea's Digital Medical Products Act, covering DMPA categories, MFDS classification, approval pathways, AI/ML requirements, cybersecurity, QMS, and labeling.

Guide to digital therapeutics regulation in 2026, covering FDA 510(k), De Novo, PMA, EU MDR classification, Germany's DiGA reimbursement route, clinical evidence, and global approvals.