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Worldwide Regulatory Submissions

  • Worldwide regulatory strategy and submission: US Pre-IDE, IDE, 510(K) and PMA, Europe CE Mark, Canada Medical Device License, Japan Shonin and Ninsho device license, China CFDA device license and Korea FDA device license.

  • Medical Device Establishment/Business license in Asia.

  • US agent representation, European Authorized Representative (EC REP), Marketing Authorization Holder (MAH/DMAH) in Japan, and Legal Agent and After Sales Agent in China.

Quality Management System

  • Development and implementation of quality management system in compliance with US QSR, CMDR, MHLW ordinance 169, ISO 13485:2016, MDSA, and MDR.

  • Scientific and technical analysis and support.

  • Audit (Internal and Supplier) development and implementation of a remediation action plan, if applicable.

  • Management and maintenance of various ISO 13485:2016, MDSAP, MDR and FDA QSR related training courses including internal standard operating procedures.

  • Management and maintenance of RA related activities tailored to your company needs.

  • Design Verification and Validation support including software.

  • Usability/ Human Factor and Risk Management.

  • Distributor Search, Evaluation, and Qualification.

  • Due diligence.

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