White Paper: 3 Strategies for Assessing IVD Product Development

The importance of having a multi-disciplined approach to IVD medical instrumentation development is outlined in a recently published white paper. In it, KMC Systems engineers, Jack Kessler and Jerry Sevigny, and senior program manager, Spencer Lovette, discuss three key elements in assessing IVD medical product feasibility and how, “assigning marketing, engineering, or operations as the sole source for defining new product features and functions can yield not only radically different products but, more importantly, products that do not meet customer needs.”  


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Topics: IVD instrument development program, In Vitro Diagnostics, ivd product development, ivd instrument development, medical product definition, ivd medical instrumentation, IVD medical product development

Medical Device Development - How to Define Requirements

One of the most important steps in medical device development is defining the requirements of your medical product early on to prevent costly revisions later and delayed time to market. Taking total product life cycle into consideration from the very start is key to success.

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Topics: medical product definition, medical device development, define medical device requirements, medical PRD