Points covered:
Policies and Standard Operating Procedures
Organization and structure of the Device Master Record
Change Implementation and revision control
Configuration Management
Document format and content review
Records management, file locations, and document distribution
Organization and personnel
Document review and approval procedures
Document system interfaces with other systems
Design documentation and the Design History File
This service includes an oral presentation with a written report on the status of your company's system, and a copy of Configuration Managementand Document Control - Fundamentals for Medical Device and Quality Certified Manufacturing
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