Quality Automation at Medical Device Leader Owen Mumford 

Owen Mumford is a global leader in medical device design and manufacturing with a commitment to innovation and customer satisfaction. Headquartered in Oxfordshire, UK with manufacturing and support operations in England, France, Germany, USA and Malaysia. The company has evolved into a medical device innovator that aims to improve the delivery of healthcare solutions for people around the world, both in clinics and at home. 

A key part of that evolution has been global expansion requiring compliance with various international regulatory bodies. The move to an automated QMS from largely manual and siloed quality operations was spurred by an unanticipated FDA inspection request for its UK operations. Owen Mumford was able to align its approach to addressing regulatory and quality challenges with its strategic digitization objectives, turning a compliance need into a strategic advantage. Now, Owen Mumford is audit-ready at all times while lowering cost across the organization, more rapidly introducing new products to market with higher quality. 

Join Paul Smith, Group Quality and Regulatory Affairs Director, and Arron Mullis, Quality Systems Project Lead who will discuss:  

• A before-and-after look at quality management automation at Owen Mumford  
• Their phased approach to QMS, starting with document control  
• How an advanced QMS solution removes data quality siloes to feed their “One Quality” initiative. 
• Why ERP integration with their QMS is a key element of their strategy  
• How to engage senior management to win support  
• Best practices and lessons learned