Medical Devices: US Law, Regulation and Practice 2016 is a seminar that covers topics such as:
- Pre-market
- Pre-submission meetings
- Design control
- What is a device
- Regulation and guidance and the role of each
- How can you tell if your product is a medical device
- Determining your classification
- The "different" products
- IVDs and LDTs
- Combination Products
- Software
- Marketing submissions
- Post marketing
- CAPA
- QSR
- Inspections
- Reporting
- Export for foreign markets
- Clinical Trials
- Other
- IDE
- Common problems in trial design and management
- Export for trials
Medical Devices: US Law, Regulation and Practice 2016 brings together attendees involved or interested in:
- Starting a company to sell health-related products
- Non-regulatory or QA areas of medical device companies
- Selling medical devices
- Financing a health care company