Overview of Regulatory Affairs for Medical Devices
BIOL-40322
The healthcare industry is dynamic and full of exponential growth. In this innovative and regulated industry, it is essential for medical device professionals to understand the business, science and regulations in developing a medical device from concept to commercialization.
In this course students will develop an understanding of the regulatory affairs environment, how to navigate and work with the FDA; and the steps and timetable to develop and commercially market medical devices in the United States. It will also highlight post market compliance issues once a device has been commercialized.
This course is designed for individuals new to the medical device and biotechnology industries or who are considering a career in Quality, Regulatory Affairs or Project Management. Professionals employed in research and development, bioengineering, quality, regulatory, law, sales and marketing who are seeking a more comprehensive picture of the medical device regulatory process will also benefit.
Topics include:
- Working with the FDA
- Device Classifications
- Product development/approval process (IDE, 510(k), PMA)
- Post-market controls
- State and federal site inspections
- Enforcement activities
- Universal Device Identification
- International Marketing
Practical Skill Development:
- Understand the Product Development Life Cycle
- Preparations for State and Federal Inspections
- How to work proactively with the FDA and California State FDB
- Understand International Regulations
