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1Blog 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 […]

2Blog Post

What is FMEA? Failure Mode and Effects Analysis Process Overview

What is FMEA (Failure Mode and Effects Analysis)? Failure Mode and Effects Analysis (FMEA) is a structured process for determining potential risks and failures of a product or process during the development phase. FMEA teams examine failure modes—those potential points of failure in a product or process — and what the failure effects (risks, harm, […]