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Developing a Testing Plan for Medical Device Design Verification
Stephen Spiegelberg Ph.D.
President, Cambridge Polymer Group, Inc.

Presentation Abstract:

A proper verification testing plan during the design of a medical device can help streamline the design process and improve the chances for a good clinical outcome by ensuring that the individual design outputs are meeting the required design specifications. Aspects of design verification include material selection and quality acceptance criteria, device specific testing according to the key performance aspects and potential failure modes, potential aging conditions that would influence shelf life and clinical life, and tests that help define manufacturing parameters and formulation requirements. In this presentation, we outline the typical test plans that we have developed and run for clients to develop new medical devices.

Presenter Biography:

Dr. Stephen Spiegelberg is the president and co-founder of Cambridge Polymer Group, where he directs a team of scientists performing contract research, analytical testing, failure analysis, and device development for the biomedical community and other fields. He chairs task groups in ASTM on the cleanliness of biomedical devices and characterization methods for materials, and is an officer in ASTM committee F04 on Medical and Surgical Materials and devices. Dr. Spiegelberg received his BS in Chemical Engineering from UW-Madison, and his Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology.

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