According to ‘Bryan Campbell article – Process Validation File’:
‘ Process validation is standard for almost any medical component, regardless of classification. While we’ve all heard stories of validations that have run amok, they can result in timely launches, production efficiency gains, reduced scrap, and improved outputs. The key to success rests on a collaborative partnership between the OEM and the CM. Clearly articulated, well-timed, authoritative communication must be the rule, not the exception.’

So, if any work on the industry (OR Not) can give us advice on how make a successful validation process for a medical device?