Quality, Risk, and Regulatory Digital Thread for Medical Device

Fueled by an urgent need to address the challenges of quality, risk, and an evolving regulatory environment, digital transformation initiatives are underway across the medical device ecosystem, which includes design and manufacturing partners. The goal is to meet regulatory reporting requirements and improve time to market for the sake of patient outcomes. Every program has been tasked with getting their digital ‘house’ in order to reduce the risk of non-compliance and drive down the costs with traceability of CTQs (Critical to Quality) over the entire product lifecycle. However, change of this magnitude is not easy and the impacts of COVID-19 have strained even the best of organizations.

Watch this short video to learn how a PLM-enabled digital thread ensures closed-loop quality and end-to-end traceability for medical devices.