A path to operational excellence with smart manufacturing for medical devices

Achieving operational excellence with smart manufacturing requires a cultural shift in how data is shared across medical device organizations. This…

Meeting the Challenges of Medical Device Manufacturing

Modern day products are becoming more complex. With the use of new materials and more parts, and increasingly incorporating electronic…

The Complexity of MDR Expectations

“regulatory expectations continue to track towards greater control, visibility, accountability, and traceability”

Design Excellence in Medical Device: Digital Evidence

“Digital Evidence to reduce costly physical tests and iterate quickly through Verification and Validation as part of our Design Excellence series for Medical Devices”

Design Excellence in Medical Device: Comprehensive Risk Management

“traceability, application, & decision support through Requirements, Design, and Verification & Validation”

Design Excellence in Medical Device: Design File Integrity

“accessible, integrated, high quality data throughout the product lifecycle for trusted compliance and product maintenance”

Design Excellence in Medical Device: Advanced Design & Re-Use

“Using a true digital twin, the stage is set for comprehensive, data based, re-use of your product development assets and processes with advanced design tool support”