Digital Health & Software

SaMD risk classification per IMDRF framework aligned with FDA and EU MDR expectations. Predicate analysis for De Novo, 510(k), and PMA pathways. Predetermined Change Control Plan (PCCP) development for adaptive AI/ML algorithms. FDA TEMPO pilot eligibility assessment and CMS ACCESS model alignment. Breakthrough Device Designation (BDD) and Total Product Life Cycle Advisory Program (TAP) applications.

Regulatory strategy for AI-enabled diagnostic software, in vitro diagnostic (IVD) platforms, and companion diagnostics (CDx) supporting pharma and biotech precision medicine programs. EU IVDR and FDA dual-pathway planning for software-driven IVD and reagent-based CDx. Integration with PACS, DICOM, LIS, and clinical workflow systems.

Digital therapeutics, AI/ML diagnostics, and SaMD solutions rarely fit traditional device coding and payment structures. Avania is world recognized as a leader in digital health market access and authored the Digital Health Laws and Regulations Report 2026 Evolution of Digital Health Reimbursement in the United States, Germany, the United Kingdom and France. Avania has successfully achieved multiple AI-algorithmic CPT codes through AMA and is actively involved in others. We develop novel benefit category positioning, HCPCS coding strategies, NTAP applications, and hybrid medical-pharmacy reimbursement approaches. FDA TEMPO pilot and CMS ACCESS model readiness assessment. Evidence strategy aligned with iterative product lifecycles including algorithm versioning and real-world performance monitoring.

Agentic AI orchestration strategy for regulated clinical workflows, including multi-model coordination, bias detection, data governance, and clinical relevance assessment. Performance validation aligned with FDA’s AI/ML-based SaMD guidance and EU AI Act high-risk system requirements. Good Machine Learning Practice integration into design controls. PCCP strategy for continuously learning and adaptive algorithms. Full IEC 62304 and 21 CFR 820 traceability.

Deep expertise in FDA radiology AI classifications including CADe, CADx, CADe/x, and CADt devices (21 CFR 892.2050-2100). Tailored biostatistical design for multi-reader multi-case (MRMC) studies, including sensitivity, specificity, AUC/ROC analysis, and fully-crossed reader performance endpoints per FDA CADe Clinical Performance Assessment guidance. Integration with PACS, DICOM, and clinical imaging workflows. Regulatory strategy spanning diagnostic imaging AI, radiomics, and imaging-guided theranostics and radiopharmaceutical companion selection programs.

Software verification: functional testing, algorithm performance benchmarking, interoperability validation, and cybersecurity testing per IEC 81001-5-1. Usability engineering (UE) and human factors (HFE) programs, including Use-Related Risk Analysis (URRA), formative and summative testing. Clinical validation: prospective studies, diagnostic accuracy trials, companion diagnostic concordance studies, and real-world performance assessment. Evidence generation aligned with FDA, IVDR, and reimbursement requirements. Includes V&V master plans, protocols, and global coordination.

Software strategy for smart wearables, remote patient monitoring platforms, and connected diagnostic systems. Interoperability frameworks including FHIR and HL7 integration. Wireless protocol compliance and data transmission security. Cloud architecture and real-time analytics platform design aligned with FDA and EU cybersecurity expectations.

Regulatory and lifecycle strategy for firmware and embedded medical device software, including RTOS environments, secure boot architectures, and over-the-air (OTA) update validation. IEC 62304 software safety classification (Class A, B, C) for embedded systems. Software of Unknown Provenance (SOUP) risk analysis

Integrated FDA, EU MDR, IVDR, EU AI Act high-risk classification, TGA, PMDA, and Health Canada software requirements built into development from concept. FDA TEMPO and CMS ACCESS alignment. One program designed for efficient global submissions.

Classification and boundary determination for DTx and CDS software. vs. Wellness/MDDS under Cures Act and MDCG 2019-11. Unparalleled knowledge and experience with premarket submission requirements (including clinical study design) for DTx products.