Developed and implemented FDA QSR/ISO 13485 compliant Quality System for startup company

Posted by Bob Duffy on April 3, 2017 in Regulatory & Standards Compliance Projects

Clinical, FDA, FDB Audit, ISO 13485, Medical Device License, QSR, Quality System

Challenge

Client needed Quality System implemented and California Medical Device License to produce units for Clinical testing.

Actions

• Worked with Client staff to define overall Quality System.
• Created drafts of all Quality System procedures and supporting forms and documents.
• Incorporated Client feedback on drafts to create final versions for release.
• Conducted pre-assessment Audit.
• Supported Client in applying for California Medical Device License.
• Supported Client during California FDB Audit.

Result

• Client passed California FDB Audit.
• Client obtained California Medical Device License.
• Client able to produce units for Clinical testing.