What Will You Learn?
- What is 510(k) regulation?
- When is a 510(k) required?
- Is 510(k) pathway right for your medical device?
- How to choose a predicate and establish substantial equivalence?
- Which type of 510(k) to submit?
- What should be included in a 510(k)?
- What is the eCopy submission process?
- How to avoid common pitfalls in your submission?
- What does the 510(k) review process entail?
What Will You Get?
- Unlimited access to this course for as long as the course remains in the active curriculum
- take as long as you need to complete the course
- revisit as often as you like
- refresh the acquired knowledge whenever you need
- Intelligent, thought provoking and entertaining quizzes and exams
- challenging questions designed by experts
- randomly pulled questions from a larger library of questions
- passing the quizzes and exams is mandatory for successfully completing the course
- provides an effectiveness measure for the training
- Course Materials
Certifications
- Certificate of Completion
- upon review of critical amount of course content
- upon successfully passing the quizzes and final exam
- Subject Matter Expert (SME) Badge
- This course is part of the "Premarket Submissions" SME Certification. It takes you one step closer to earning that SME Badge.
SuperSmart Points
- You earn 10 SuperSmart points for taking this course.
- You need to redeem 60 SuperSmart points to take this course for free.
And More...
- Ongoing interactions and networking with other course participants
- Interactions and follow-up questions with the course author
- Provide rating and review comments on the course
- Author: Jeff Hang