Hi
Medical Device Manufacturers know... All processes associated with designing, manufacturing, packaging, labeling, storing, installing, or servicing a finished device intended for human use must be validated.
The FDA defines process validation as:
”the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”
The FDA also mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated.
Thanks
Lavanya Sreepada