Summary

Certified Quality Auditor, medical manufacturing inspection, food manufacturing inspection, audits, respiratory support devices, liquid supsension administration, emergency airway management, critical care, neonate care, community hospital, engineering, medical devices, FDA 510k, FDA PMA, FDA 513g, technology transfer, medical technology

Description

Auditing and Consulting for current Good Manufacturing Practice (cGMP) for medical, pharmaceutical, and supplement manufacturing and test labs. 21 CFR 820 and part 11. Also 21 CFR 806 and 802 for adverse event analysis. Expert witness consulting and testimony for medical device and diagnostics marketing compliance. ISO 13485 and ISO 14971. Research and development of critical care, airway management, and emergency airway devices for pediatrics and adults. Pulmonary liquid suspension delivery devices. Biomedical and Medical Device Engineer.

Special details

Bench top simulators, calipers, SOPs for manufacturing and quality control. Secure cloud storage and sharing for documentation and compliance with FDA and DoD cybersecurity policies.

Profile

  • Incorporated in
    California
  • Established since
    2012
  • Main/Branch
    Branch

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