Digital Health & AI

Manage third-party cybersecurity risk for connected medical devices using FDA Section 524B, QMSR and ISO 13485 controls, SBOMs, vendor assessments, and threat modeling.

Guide to AR and VR medical device regulation in 2026, including FDA classification, product codes, 510(k) and De Novo routes, cleared devices, surgical navigation, therapeutic VR, and human factors.

Learn how HL7 FHIR, IEEE 11073, and DICOM support medical device interoperability, including CMS mandates, FDA expectations, and implementation guidance.

Implement Privacy by Design in connected medical devices, with GDPR, HIPAA, data minimization, consent, anonymization, and 2026 privacy expectations.

How to choose Agile, Waterfall, or hybrid medical device software development under IEC 62304, with AAMI TIR45 mapping, design controls, and auditor evidence expectations.

How to design decentralized and hybrid clinical trials for medical devices, covering FDA guidance, remote visits, digital endpoints, wearable data, eConsent, and implementation planning.

Guide to electronic IFU rules for medical devices, covering EU Regulation 2025/1234, FDA 21 CFR Part 801, website access, QR codes, paper fallback, IVDR, SaMD, and validation.

Learn how medical device companies can implement ISO 27001, align ISMS controls with ISO 13485 and FDA cybersecurity expectations, and plan certification.

Guide to classifying SaMD, SiMD, and embedded medical device software, with IMDRF definitions, IEC 62304 risk classes, FDA and EU MDR pathways, and documentation strategy.

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.