06.23.22 -- MDSAP Audit Approach Updated From Rev. 6 To 7

We review what items a device manufacturer and supplier should align on and what essential assets a manufacturer should look for in a supplier team.

When subcontracting medical or optic injection-molded components, do you carefully evaluate your molder’s validation process? There is only one approach that is proven to keep your molded parts “in spec”: decoupled molding.

While pressure and flow rate may be sufficient parameters to consider when selecting a pump in some industrial applications, medical device requirements are more demanding and require a more thorough review of pump parameters.

When a top-30 medical device original equipment manufacturer needed to close a legacy facility producing a Class III implantable device as part of its consolidation strategy, it opted to explore oursourcing rather than an in-house option.