Case Study: Complete Design Control System

A medium-size manufacturer of invasive therapeutic products wanted an improved design control process that could be used equally well with both disposables and systems.

AlvaMed developed an approach that made use of detailed, self-tutoring templates for all DHF document types, combined with a basic set of governing SOPs that unified policy statements with tutorial content. The methodology permits the use of multiple templates for each DHF document type, providing the flexibility to use the system equally well with both disposables and systems.

The system has been successfully used with both disposables and complex software-containing electromechanical systems.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control