Controlled innovation, including broad patient participation in clinical trials, has been key to the success of every medical device manufacturer.
Traditionally design, quality and regulatory teams have worked in silos with a huge effort required prior to submission to bring all the information together. With more companies looking to transform and join these silos together, adopting a “Digital Thread” to ensure seamless and efficient transfer of information around the business, the opportunities for improvement are immense. Quality in this context means much more than simply driving down the costs of line failures, scrap, rework, and warranty claims. Though critically important to profitability, reducing the costs of poor quality is insufficient without also delivering positive patient outcomes, reducing the number of adverse or severe events, and the ability to rapidly respond to an event should it occur.
With European Medical Device Regulations (MDR) deadlines now being introduced, the task gets even harder. This webinar explores how the Digital Thread, with a foundation of PLM, can be leveraged for improving both Design Control and Quality Management in this innovative, but regulatory-oriented, environment.
Who Should attend:
• Engineering/Design Executives & Managers
• Quality & Regulatory Executives & Managers