Risk Management for Medical Devices: How to Get Everybody Speaking the Same Language

Description

Learn how to align disparate stakeholders by creating a common terminology and understanding of the Risk Management Process. Having misaligned stakeholders can extend the schedule and budget. Sunrise will present methods to improve alignment and set the groundwork for the Risk Management Process.

Key Takeaways:

• A basic understanding of the Risk Management Process
• Strategies for Fostering Team Alignment
• Mastering the Language of Risk: Key Terms Explained & Training Best Practices

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SPEAKER

Christopher Perry Senior Principal Systems Engineer Sunrise Labs, Inc Chris Perry is motivated by opportunities to help develop and launch life-changing medical products and continuously looks for ways to refine his skill sets to improve program efficiency. Chris has worked on an extensive array of sophisticated fluid handling systems and personal mobility devices, all US FDA Class II or higher devices. This work has provided Chris with substantial experience in most aspects of the medical device product development process; concept development and specification generation, technical team leadership responsibilities, qualification, standards compliance and FDA approval process, manufacturing transition/support, and product maintenance. Chris holds a BSME Degree from the University of Connecticut, with a concentration in Electrical Engineering.