DESIGN CONTROL DOCUMENT TEMPLATES CASE STUDY
CHALLENGE:
A medium-sized manufacturer of invasive therapeutic products wanted an improved design control process that could function well with both disposables and systems.
APPROACH:
AlvaMed developed an approach that made use of detailed, self-tutoring templates for all DHF document types.
RESULTS:
The templates have been successfully used to provide a thorough and consistent DHF for both disposable and system products.