Medtech

AS9100 Aerospace Quality Management

Evaluate AS9100D aerospace quality management system compliance, building on ISO 9001 with aerospace-specific requirements for safety, reliability, …

Assessment for pharmaceutical contract manufacturing organizations covering cGMP compliance, quality agreements, and third-party oversight

EU AI Act Compliance Assessment

Evaluate compliance with EU Artificial Intelligence Act for high-risk AI systems, covering risk management, data governance, transparency, human …

EU IVDR 2017/746 - IVD Compliance Assessment

Evaluate compliance with European In Vitro Diagnostic Regulation 2017/746 for diagnostic tests, companion diagnostics, and laboratory-developed tests …

EU MDR 2017/745 Compliance Assessment

Evaluate compliance with European Medical Device Regulation 2017/745 covering device classification, quality management, clinical evaluation, …

Assessment for EAR/ITAR compliance, deemed export controls, and research security for organizations with foreign national access or international …

FDA AI/ML Software as Medical Device (SaMD)

Evaluate FDA AI/ML-based Software as Medical Device compliance per 2021 guidance, covering predetermined/adaptive algorithms, algorithm change …

FDA Mobile Health App Compliance

Evaluate mobile medical app compliance with FDA guidance, 21 CFR Part 11, data security, clinical validation, and app store requirements

IEC 62366 Usability Engineering Assessment

Evaluate medical device usability engineering per IEC 62366-1:2015, covering user interface design, formative and summative usability testing, and …

ISO 14971 Risk Management Assessment

Evaluate medical device risk management per ISO 14971:2019, covering risk analysis, risk evaluation, risk control, and post-production risk monitoring …

ISO 62304 Software Lifecycle Assessment

Evaluate medical device software development per ISO 62304:2006/AMD1:2015, covering software safety classification, development processes, risk …

Lab & Facility Building Code Compliance

Evaluate building and fire code compliance for laboratory, cleanroom, and BSL facilities covering construction, life safety, egress, and specialized …

Remote Patient Monitoring (RPM) Compliance

Evaluate remote patient monitoring program compliance covering CMS reimbursement, device accuracy, data transmission security, and clinical workflows

UDI Compliance Assessment (FDA & EU)

Evaluate Unique Device Identification compliance for FDA (21 CFR Part 801/830) and EU MDR (Article 27), covering UDI assignment, labeling, …