Define requirements
Intended use · Drawings · Critical specifications
01 / MEDICAL DEVICE CDMOMedical Device
Medical Device
CDMO collaboration
From design requirements to quality deliverables, review each applicable activity.
WHAT WE DISCUSS
Medical device CDMO and contract manufacturing: how to start.
Begin a medical device contract manufacturing or CDMO enquiry with intended use, materials, drawings, critical specifications, and quality and validation requirements. OSSAWARE evaluates the proposed design, manufacturing and downstream activities; the scope of work requires valid documents and project review.
Plan processes
Applicable design and manufacturing scope
Quality deliverables
Packaging · Labeling · Final release
SCOPE FIRSTEach category
Each category
has its own activity limits.
Some permitted categories include manufacturing; others list only design, packaging, labeling and final release. The complete, valid approval documents determine the scope of work.
View the complete QMS scope ↗