Simplifying Global Compliance
Your employees can be trained using brief 10-minute modules that are set up the way adult learning experts recommend. These carefully planned modules explain the regulations in short, clear, simple chunks that ALL of your employees will be able to follow, understand — and retain.
Whether you need to help your company convince the FDA to accept a predicate device in a simple 510(k) filing or you’re responsible for implementing UDI across a family of high-risk implantable devices, there’s one thing all regulatory professionals need. The most up-to-date, latest FDA regulations are available in this best-seller.
Despite FDA prodding, recent device clinical trials include only 22% women. Are you sure your clinical trials are gender-balanced? Two leading device researchers help you understand and cope with this still-evolving area of government oversight.
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