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UDI Compliance

EUDAMED & GUDID registration, labeling integration, and direct marking solutions

Technical files, Design History Files, EU MDR/IVDR submissions, and FDA 510(k)/PMA

Clinical Evaluation Reports, literature reviews, PMCF planning, and data collection

Feasibility studies, risk management, design validation, and market analysis

Regulatory roadmaps, pathway identification, MDR/IVDR transition, and notified body interaction

ISO 13485:2016 design & implementation, FDA QSR, gap analysis, SOPs, and audit readiness

Regulatory compliance audits, documentation reviews, and risk assessment for acquisitions

NMPA, PMDA, CDSCO, MFDS, SFDA, and MOHAP regulatory transition support

IEC 62304 lifecycle documentation, cybersecurity compliance, and secure development

Drug-device combination regulatory strategy, PMOA determination, and Notified Body Opinion support

EU MDR/FDA labeling compliance, ISO 15223-1 symbols, sterile packaging, and multi-language IFU

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