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402Blog Post

Three Ways to Proactively (vs Reactively) Incorporate Design Controls in Medical Device Product Development

Incorporating Design Controls can be a daunting task for medical device product development teams. For a variety of reasons, including unfamiliarity of regulatory expectations, inexperience with implementation, or viewing them as a burden preventing innovation, too many teams incorporate Design Controls reactively instead of proactively. Here are three ways to proactively and practically incorporate design […]

410Guide

What is Systems Engineering?

In this chapter, learn more about the fundamentals and processes of systems engineering, the role of a systems engineer, and the "V" model.