Medical Device Regulatory Consulting & Strategic Planning

Global regulatory pathway analysis and product classification, pre-market strategy development for FDA, EU MDR, JPAL, TFDA and other major jurisdictions.

Device V&V Strategy Planning and Technical Documentation

Development of regulatory-compliant verification and validation (V&V) plans covering performance testing, biocompatibility, electromagnetic compatibility (EMC), software validation, sterility, packaging, transportation, clinical evaluation, and risk management; along with professional preparation and review of risk management reports, clinical evaluation reports (CER), post-market surveillance (PMS) plans and reports, post-market clinical follow-up (PMCF) plans and reports, STED, 510(k), De Novo, PMA submissions, EU MDR Technical Documentation, and Common Specifications.

Quality System Consulting & Implementation

ISO 13485, MDSAP, and QSR 820 compliance consulting, quality management system establishment and optimization, internal audits, supplier quality management, CAPA, MDR/Vigilance reporting, and post-market surveillance.