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.