SaMD

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.

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.

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.

Learn how the EU AI Act applies to AI-enabled medical devices, including high-risk classification, MDR/IVDR overlap, conformity assessment, and 2026 deadlines.

Guide to AI and machine learning medical device regulation, covering FDA AI/ML policy, PCCPs, SaMD classification, 510(k), De Novo, EU MDR, and Good Machine Learning Practice.