An Intelligent Approach to Design Control for Medical Devices
Getting a handle on the number one cause of medical device product recalls and audit observations
For medical device developers, effective design control has always been the key to ensuring safety and overall quality, while meeting regulatory requirements, controlling costs and reducing delays in product introduction. But the challenges to implementing effective design control are growing rapidly, as device complexity and regulatory requirements increase – a reality underscored by the fact that errors in design controls remain the number one cause of medical device product recalls and audit observations.
Dealing with these challenges calls for an intelligent approach to design control. This webinar will illustrate the concepts and components of an integrated, systematic, logical system for building and maintaining product design control for medical devices.
The webinar will include a discussion of:
- The business case for becoming data-driven and document smart by powering your design process across mechanical, electrical, and software engineering teams with increased efficiency, speed and clarity to produce safe, high quality devices
- The components of a holistic solution for integrating requirements and risk management, test planning and execution, and design output management, including design history files (DHF) and device master records (DMR)
- How to ensure you have a 100% accurate BOM with traceability from user needs all the way to the shop floor and the device history record (DHR)
Speakers:
- Laurence Sampson, Senior Director, Medical & Lifescience Industry Strategy, Siemens PLM Software, Inc
- Jim Thompson, PhD, Senior Director, Medical & Lifescience Industry Strategy, Siemens PLM Software, Inc.