Aviation Parts to Medical Devices: Bridging the Gap
This course is verified by Probitas Authentication as meeting the AS9104/3A requirements for continuing Professional Development.
This one-day program is designed to provide introductory information for those organizations who are considering transitioning from the Aeronautic, Space and Defense industry to the Food & Drug Administration (FDA), Medical Device Manufacturing market.
Reviewing essential information necessary to understand and successfully begin the journey to FDA Medical Device approval, this course will examine many of the controls between the AS9100 Standard and FDA Regulations and identify the similarities.
What Will You Learn
- Describe the medical device manufacturing landscape
- Summarize the significant global players and identify their roles and responsibilities
- Contrast the high-level FAA regulations and the FDA Medical Device regulations
- Recognize device classification basics
- Describe the steps involved to bring products to market
- Discuss what to do next when transitioning
Is This Course For You
This training program is designed for quality and engineering professionals in the Aviation, Space and Defense industries who are interested in entering the FDA Medical Device Manufacturing Approval business sector.