Newsletter | April 13, 2021

04.13.21 -- AI/ML-Enabled Medical Devices -- 4 Keys To Obtain Global Regulatory Approval

 
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Keys To Successful Design For Manufacturability

A product’s manufacturability is influenced by the materials used, requested tolerances, part geometry, process control limitations, and more. A successful DFM process considers each of these factors from the start.

Beyond The Quote: Total Cost Of Ownership With Supply Chain Partnerships

Critical components cannot be sourced like simple parts; they demand greater vendor/customer collaboration, profound depth of knowledge, and a supplier committed more to the relationship than the sale.

A Balancing Act: Cost Vs. Reliability For Medical Device Development

For a medical device development company, when applying the business lens, balancing value and reliability is a constant consideration.

Risk Management And The Combination Product Testing Strategy

Understanding combination product risks at the interfaces is critical. Components are often sourced at opposite ends of the globe and are proven to be robust due to investments in research, development, and testing. It is essential to have an equal and complete understanding of all components where they come together at the interfaces where the risks are hidden.

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