SaMD Regulatory, Submission and Representation Services
From regulatory strategy and QMS to TFDA / FDA submissions and Taiwan representation
Beyond developing and commercializing its own SaMD product, AItewan provides regulatory consulting, submission support, and Taiwan market representation for medical software and AI-based SaMD teams — covering Taiwan TFDA Class II strategy, U.S. FDA 510(k) preparation, QMS implementation, cybersecurity documentation, validation planning, submission support, and local commercialization.
- TFDA Class II
- FDA 510(k)
- ISO 13485
- Medical-device cybersecurity
SaMD regulatory, compliance and representation services
Submission strategy, QMS, cybersecurity documentation, clinical validation and representation
TFDA Class II Submission Support
Submission strategy for Taiwan TFDA Class II devices: classification, intended-use drafting, technical documentation, risk management, software V&V, clinical evaluation and reviewer communication.
TFDA Clearance and Taiwan Representation
Support for domestic and international medical-device and SaMD companies entering Taiwan: TFDA clearance planning, submission documentation, reviewer communication, post-market compliance, and Taiwan sales representation based on the selected partnership model.
U.S. FDA 510(k) Submission Support
Premarket notification preparation: predicate analysis, intended use / indications for use, software and cybersecurity documentation, performance and clinical validation, and submission packaging.
ISO 13485 QMS Implementation
Quality management system build-out: design and development controls, document control, supplier management, risk management, CAPA, change management, post-market surveillance and audit readiness.
SaMD Software Life-cycle Documentation
Documentation architecture for medical-device software: SRS, software architecture and design, verification and validation, release notes, known anomaly lists, SOUP management and maintenance plans.
Cybersecurity Testing & Documentation
Cybersecurity documentation and test planning for TFDA Class II review: threat modeling, risk assessment, SBOM, penetration test planning, remediation records and post-market security processes.
Clinical Validation & Performance Design
Validation dataset planning, ground-truth workflows, statistical methods, performance metrics, subgroup analysis, reader studies and clinical evaluation reports aligned with TFDA / FDA expectations.
IP & Technology Strategy
Identifying protectable technology from product, algorithm and workflow perspectives, and working with patent counsel to build a development-aligned IP strategy.
From product development to regulatory clearance
From Product Development to Regulatory Clearance
AItewan is not merely a regulatory consultancy — it is a medical-AI team with hands-on experience in SaMD product development, hospital deployment, clinical validation, quality systems, TFDA approval, U.S. FDA 510(k) clearance, cybersecurity documentation, patent strategy, and Taiwan market access.
- We do not just know the regulations — we have cleared an AI SaMD ourselves
- We do not just write documents — we understand clinical workflows and DICOM integration
- We do not just consult — we help build product strategies that actually ship
- Hands-on TFDA, FDA, ISO 13485, cybersecurity, IP and market-access experience
- From product development to hospital deployment — bringing medical AI into the clinic
Ready to start your SaMD regulatory plan?
Whether you need TFDA Class II strategy, FDA 510(k) preparation, ISO 13485 QMS implementation, cybersecurity documentation, clinical-validation design or Taiwan market representation, AItewan provides practical support grounded in real SaMD experience.