CardioMed Device Consultants can help train and support your staff. Having well-trained and knowledgeable individuals will create a seamless blend of your regulatory, marketing, and technical departments. The following are some of the key regulatory seminars we can provide your staff. In addition, we would be happy to discuss any of your specific training needs.
- FDA History and the Food, Drug, and Cosmetic Act
- FDA Laws and Regulations
- FDA Organization, Structure, and Function
- CDRH Goals, Initiatives, and Programs
- FDA Medical Device Regulations
- Pre-Market Submissions and Requirements
- Investigational Device Submissions and Requirements
- Medical Device Labeling Requirements
- FDA New Medical Device Guidance Documents