Regulatory affairs professionals are a critical element in the medical device development process, but are often overlooked for their impact to business and product development strategy. The most efficient, cost-effective and compliant way to get medical devices to market worldwide is to involve regulatory affairs early and in every aspect of a medical device’s lifecycle.
Although hard to believe, there was a time when medical devices could be developed without any government oversight. Recently, strategic regulatory affairs input has become just as important as how your device is designed, manufactured and marketed. The new regulations have changed the RA professional’s role and have transformed the relationship between regulatory affairs and every other department within a medical device organization.
This webcast will demonstrate how the RA professional is a key strategic player starting with premarket planning and continuing through product development stages, manufacturing, and post market activities, and review best practices for engaging cross functionally for positive impacts across business groups.
As Director of Regulatory Affairs, Susan brings over 19 years of medical device industry knowledge across engineering, quality and regulatory affairs to the Network Partners team. Susan is a RAC Certified regulatory affairs professional specializing in the medical device products industry for key markets US, EU and Canada.