The FDA Medical Device Approval Process: Preparation of 510(k)s, IDEs, PMAs 2015 is an event dedicated to an overview of the requirement to obtain FDA permission to market a Medical Device products.
Topics
- Preparing contents of the 4 types of 510(k)s
- Navigate the FDA medical device approval system
- Preparing contents of a PMA
- Preparing contents of an IDE
- Significant risk devices
- Non-significant risk devices
Who should Attend
Senior attendees involved or interested in:
- Quality Personnel
- Regulatory Affairs Personnel
- Research Personnel
- Clinical Personnel
- Auditors
- Manufacturing Personnel
- Personnel who require an understanding of the FDA Medical Device Approval Process
- Legal Personnel
