Newsletter | June 23, 2022

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

Featured Editorial
Industry Insights
Sketch To Scale: The Importance Of Relationship-Building At The Prototyping Stage

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.

The Only Validation Approach That Gets — And Keeps — Your Molded Part In Spec

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.

Key Considerations For Selecting A Medical Pump

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.

Manufacturing Transfer Requires Cross-Functional Leadership, Resources, And Open Communication

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.  

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