Purchasing Process for paper IFU Printing Company

bimeri

Starting to get Involved
A simple question: As a class IIa medical device manufacturer, we get a printing service for our IFU from a printing company to get the paper-based IFU. Should we categorize this supplier as critical? Moreover, is ongoing monitoring and periodic re-evaluation necessary?
 
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ScottK

Not out of the crisis
Leader
Super Moderator
A simple question: As a class IIa medical device manufacturer, we get a printing service for our IFU from a printing company to get the paper-based IFU. Should we categorize this supplier as critical? Moreover, is ongoing monitoring and periodic re-evaluation necessary?
I would consider this supplier critical if I was in your shoes. I worked in class I devices and we considered IFU a critical component.

I also worked for a company that printed drug instruction sheets (those ones folded a bazillion times) for pharma customers. We were a critical supplier and were audited regularly by our customers. Every other year at least.
 
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