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LiveWorx 2017

FDA’s Case for Quality - Investing in Quality Pays

Session Description

Case for Quality is a multi-year FDA led initiative to develop best practices to improve product and manufacturing quality beyond compliance with regulatory requirements. The effort is being coordinated by Medical Device Innovation Consortium (MDIC), a partnership between FDA, industry and other collaborators. Because of repetitive quality issues and stagnant data among device manufacturers, the FDA and medical technology companies should: 1) Collaborate on practices in device design and production to enhance patient safety and access to high quality medical devices. 2) Change focus from just regulatory compliance to sustained product quality. 3) Continually engage all parties to advance device product quality. All of this leads to Windchill QMS, a solution that creates a closed loop system established on a single repository, harmonized with ISO 13485 which is a quality management standard for medical devices. The solution covers the complete lifecycle of a medical device from initial conception to final disposal. We will share USDM Life Sciences journey on all the points outlined above.


Session Presenter
Additional Information
Industrial Internet of Things
Healthcare & Medical Devices
How to increase the Assurance of Product Quality.
The many ISO 13485 and 2016 metrics changes.
How Windchill QMS integrates your PLM, risk management, document control, product design, nonconformance, complaints and CAPA processes within your organization.
Breakout Session
45 minutes
Session Schedule