Digital Health & AI

Comprehensive regulatory and validation strategy for next-generation sequencing (NGS) in vitro diagnostic devices — covering FDA pathways (510(k), De Novo, PMA), proposed CDx reclassification, EU IVDR classification, wet lab and bioinformatics pipeline validation, variant calling, reference databases, clinical validity, cybersecurity, and post-market obligations.

Regulatory strategy guide for surgical robot manufacturers — covering FDA classification (510(k), De Novo, PMA), autonomy levels, software controls (IEC 62304), electrical safety (IEC 60601), usability (IEC 62366), clinical evidence expectations, EU MDR requirements, training programs, and post-market surveillance.

Health Canada's 2026 regulatory reforms introduce expanded Terms & Conditions (T&C) powers for Class II–IV devices, new AI/ML-enabled medical device guidance, mandatory Regulatory Enrolment Process (REP), IMDRF Table of Contents requirements, and updated significant change guidance. This guide covers every major change effective January–April 2026 and what foreign manufacturers must do to maintain Canadian market access.

FDA's February 2026 cybersecurity guidance and Section 524B of the FD&C Act make penetration testing, vulnerability scanning, and fuzz testing mandatory evidence for connected medical device submissions. This guide covers what testing is required, how to structure results, common FDA deficiencies, EU MDR cybersecurity expectations, and how to build a testing program that satisfies both regulatory frameworks.

On February 3, 2026, the FDA reissued its premarket cybersecurity guidance aligned with the new Quality Management System Regulation (QMSR) and ISO 13485:2016. This guide covers what changed, what stayed the same, how to map cybersecurity to ISO 13485 clauses, and practical steps for manufacturers building connected devices in 2026.

On January 6, 2026, the FDA significantly expanded its General Wellness policy, now allowing certain wearable devices that estimate blood pressure, blood glucose, oxygen saturation, and other physiologic parameters to qualify as non-regulated wellness products. This guide covers the new criteria, FDA's illustrative examples, the line between wellness and medical device claims, and what manufacturers must do to stay compliant.

Complete guide to third-party vendor cybersecurity risk management for medical devices — FDA Section 524B, QMSR ISO 13485 alignment, SBOM requirements, vendor risk assessment frameworks, MITRE threat modeling, and implementation strategies for connected device manufacturers.

Complete guide to augmented reality and virtual reality medical device regulation — FDA classification, product codes, 510(k) vs De Novo pathways, the 104 FDA-cleared AR/VR devices, surgical navigation, therapeutic VR, and human factors requirements in 2026.

How HL7 FHIR, IEEE 11073, and DICOM standards enable medical device data interoperability — including the Caliper Accelerator, CMS mandates, FDA premarket expectations, and implementation guidance for manufacturers.

How to implement Privacy by Design principles in medical device development — covering GDPR, HIPAA, data minimization, consent management, anonymization, and the 2026 regulatory landscape for connected devices and wearables.

How to choose between Agile and Waterfall for medical device software development under IEC 62304 — AAMI TIR45 guidance, design control mapping, hybrid models, and what auditors actually look for.

How to design and run decentralized clinical trials for medical devices — FDA final guidance, hybrid vs fully remote models, digital endpoints, wearable data capture, eConsent, and step-by-step implementation framework.

Complete guide to electronic Instructions for Use (eIFU) for medical devices — EU Implementing Regulation 2021/2226 as amended by Regulation 2025/1234 expanding eIFU to all professional-use devices, risk assessment requirements, labeling obligations, EUDAMED UDI integration, FDA electronic IFU policy under 21 CFR Part 801, paper IFU fallback rules, IVDR provisions for IVDs, SaMD-specific guidance, validation expectations, and implementation checklist.

How medical device companies can implement ISO 27001 for information security — ISMS requirements, certification cost and timeline, integration with ISO 13485 and FDA cybersecurity requirements, IEC 62443 comparison, and step-by-step implementation roadmap.

Complete guide to distinguishing SaMD, SiMD, and embedded software for medical devices — IMDRF definitions, IEC 62304 classification, FDA and EU MDR regulatory pathways, MDCG 2019-11 guidance, documentation requirements, and practical decision frameworks for medtech manufacturers.

Complete guide to GDPR compliance for medical device and IVD manufacturers — special category health data, Data Protection Impact Assessments, DPO requirements, lawful bases for processing, cross-border transfers, and how GDPR intersects with EU MDR, IVDR, and the AI Act.

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.

The complete guide to managing Software of Unknown Provenance (SOUP) under IEC 62304 — identification, risk assessment, safety classification, documentation requirements, open-source management, and post-market surveillance strategies.

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.

A comprehensive guide to wireless and RF regulatory compliance for connected medical devices — FCC equipment authorization, EU Radio Equipment Directive (RED), wireless coexistence testing, cybersecurity requirements, risk management, and global market access strategies.