As the medical world continues to shift toward value-based healthcare, the need for product quality and efficacy improvements, together with cost containment, is becoming more pressing. The traditional focus on pure compliance in addition to siloed business processes and systems impede companies’ abilities to deliver on product quality and patient safety standards.
To change the mindset of the medical device industry, the FDA started the Case for Quality (CfQ) initiative, which recommends manufacturers focus more time up-front on quality by design versus pure compliance. This new strategy relies heavily on digital transformation and harmonization of cross-functional activities that contribute to the safety and efficacy of each device.
CONMED faced this challenge head-on and augmented their CfQ journey by unifying core regulated processes, quality management, and product development in a single system.
Listen to this webinar, and hear how CONMED:
- Leveraged FDA’s CfQ to build a digital quality management transformation strategy and gain organizational alignment
- Instilled a culture of quality that is helping the organization navigate the global pandemic
- Reduced the cost of poor quality and improved operational efficiency
- Improved the safety and efficacy of products
During the session, attendees learned about enabling technologies and practical implementation approaches that will help you get started with your digital quality management initiative and work towards enterprise-scale success.
Axendia’s Market Analyst, Sandra K. Rodriguez moderated a panel discussion featuring Noah Cumby, Corporate Program Manager, QS at CONMED - David Wolf, Sr. Manager at Kalypso, – and Marc Fowler, PTC’s PLM Life Sciences Sales & Strategy Leader.
Presenters:
Sandra K. Rodriquez
Market Analyst,
Axendia
Noah Cumby
Corporate Program Manager
QS at CONMED
David Wolf
Senior Manager
Kalypso
Marc Fowler
PLM Life Sciences Strategy Leader
PTC