A Systems Engineering Approach To An Integrated Design Controls and Risk Management Framework in Medical Device Development

Yeshwanth Reddy (AtriCure)
Arun Mathew (AbbVie)
Yeshwanth Reddy (Incose)

Keywords
Design Controls;Risk Management;Medical Device Product Development
Abstract
The presentation highlights the pivotal role of design controls in medical device development. It advocates for a shift from reactive to proactive risk methodologies in application of design controls, emphasizing a systems thinking mindset. Key insights cover an integrated framework for design controls and risk management, enabling teams to assess requirement criticalities and make informed choices early in the product lifecycle, prioritizing patient safety.