Design Controls Procedures

This documentation package provides a Design Control SOP that ensures development activities are executed in compliance with regulatory and quality requirements and result in a safe and effective product. Design Controls Documentation Package includes template procedures and forms:

• Design Controls Standard Operating Procedure

• Design and Development Plan

• Marketing Requirements Document

• Product Requirements Document

• Material Specification

• Test Protocol and Report

• Design Review Form

• Usability Engineering File Summary

• Usability Engineering Plan

• Usability Test Protocol