SaMD

A comprehensive guide to Saudi Arabia's SFDA MDS-G27 (2025) regulation on digital health. Understand the boundary between medical devices and wellness software.

Compare how Saudi SFDA MDS-G23, Brazil ANVISA RDC 657/2022, Nigeria NAFDAC and Kenya PPB regulate Software as a Medical Device — definitions, risk classes, and filing routes.

EU AI Act Omnibus extends medical device AI compliance to August 2, 2028. Dual MDR strategy, data governance, human oversight, tech doc integration, and preparation timeline.

EU Commission's May 2026 draft Article 6 high-risk AI classification guidelines: two-path system for medical devices, consultation deadline June 23, and compliance deadlines in 2027-2028.

Software verification vs validation for medical devices — FDA expectations, IEC 62304 activities, documentation, traceability, and the design control process.

Regulatory guide to connected autoinjectors and smart pens, covering FDA 510(k), De Novo, EU MDR classification, SaMD accessory issues, cybersecurity, and human factors.

Guide to Health Canada's 2026 MLMD guidance for AI/ML devices, including PCCPs, data quality, bias controls, lifecycle risk, digital submissions, and FDA/EU comparisons.

How to test AI-enabled medical devices for demographic bias, validate fairness statistically, document FDA and EU submissions, and monitor post-market performance.

Guide to SaMD clinical evaluation, covering valid clinical association, analytical validation, clinical performance, FDA expectations, EU MDR evidence, and real-world data.

Explains the May 7, 2026 EU AI Act omnibus deal, product safety exemptions, revised timelines, and compliance actions for AI-enabled SaMD and IVDs.

Method for mining FDA AI-enabled device and 510(k) databases to identify predicates, compare technology, avoid weak arguments, and build a defensible predicate matrix.

Prepare for IEC 62304 Edition 2 with process rigor levels, broader health software scope, AI/ML lifecycle provisions, cybersecurity integration, and compliance timelines.

Build FDA PCCP drift monitoring protocols for AI imaging devices, including dataset shift, scanner drift, thresholds, cadence, retraining triggers, and submission boundaries.

Guide to FDA's January 2025 draft guidance on AI-enabled device software functions, including TPLC controls, data management, bias mitigation, transparency, and submission content.

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.

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

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.

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.

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