Chris Henderson Email & Phone Number

United States

Indiana, United States

San Francisco Bay Area

Oakland, Ca

Oversaw the development of the Technical Engagements program for Neozene to develop the quality and regulatory consulting team.

• Design and implement total quality management system for the client• Manage and enhance the company CAPA system, ensuring assignment, investigation, root cause analysis, correction, and closure of open company CAPAs• Train management staff to understand and use the CAPA system for an ISO 13485 QMS• Design and implement customer complaint handling process• Provide support and knowledge required for the client to attain ISO 13485 certification• Assist in the design and implementation of the company-wide training system• Author a new quality manual for the client to assist in implementing the company’s new vision of Quality• Author a quality plan to help facilitate the client’s vision of moving toward a total quality system revamp• Assist in the updating of company-wide complaint systems to better facilitate complaint handling• Submit an expedited 510(k) for the client via third party reviewer• Provide FDA Audit support for the client• Manage foreign government registrations and export requirements for medical devices in Japan, Taiwan, Russia, Lithuania, and Canada• Manage projects to research and implement new market requirements for medical device export• Author STED Canadian registration amendments for pre-existing medical products

Mountain View, Ca

Foreign government registration, Health Canada Technical Files, JIST Japanese Government Tech File Submission

Sunnyvale, Ca

Foreign government registration. Pre-market 510(k) submissions, EU Technical Files

Kansas City, Missouri Area

Foreign governement registration, 510(k) clearances, CAPA, Complaint Handling, Nonconforming Product and Processes, Internal Audit, Document Control, Calibration Control.

New Century, Kansas