The 3rd Annual FDA Boot Camp Devices Edition 2013 is a conference that covers topics such as:
- An overview of medical device regulations
- The organization, jurisdiction, functions, and operations of the FDA
- Clinical trials and IDEs
- The classification of devices and the concept of "risk-based" classification
- The premarket approval process (PMAs) and drug labeling and promotion
- The 510(k) clearance process – what you need to know now and what to expect in the future
- QSRs vs. cGMPs and ISO
- General post-market controls and MDRs
- Recalls, product withdrawals, and FDA oversight authority
- Mitigating the impact of enforcement actions
The 3rd Annual FDA Boot Camp Devices Edition 2013 brings together:
- In-house counsel with responsibility for:
- Patents and IP
- Litigation
- Investment Bankers and Venture Capitalists
- Securities Attorneys
- Attorneys whose practices focus on:
- Patent litigation
- Products liability litigation
- Patent prosecution
