Sector Electronics - Electronic Product Design

Problem

A national medical equipment service company came to us with a need to establish the necessary internal controls and documentation to allow them to begin manufacturing medical devices and to meet the FDA requirements for "Good Manufacturing Practices" (GMP).

Solution

After an analysis of their current capability and existing documented procedures, we generated a list of the missing elements. Working with their staff in various areas of their operation, we were further able to ascertain their standard methods for accomplishing tasks and documented those processes.

We generated a GMP guideline document that referenced all the various "Standard Operating Procedures" (SOP) that had been created. This guideline established the standard methods for design, verification, validation, material control, document control and manufacturing. Each SOP created detailed steps and processes required for each aspect of these operations.

After the documentation was in place, we trained their personnel in the methods and processes required to conduct their business in a way that would satisfy the FDA requirements for GMP.

This customer later asked us to help them develop several products and to assist them through the FDA approval process.