Design Control Document Templates Case Study

QMS-Compliance
CHALLENGE:
Medium-size manufacturer of invasive therapeutic products wanted an improved design control process that could be used equally 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