Generate clinical evidence demonstrating device safety and effectiveness through systematic evaluation and literature review.
What is the purpose of a clinical evaluation plan and report?
How are clinical benefits documented?
How should claims be handled initially for a product?
What is the best practice for updating clinical evaluation documents?
How do we determine the number of participants required for clinical trials?
What are the requirements for the clinical evaluation team?
How should equivalence to predicate devices be demonstrated?
What is valid clinical association for software medical devices?
How often should clinical evaluation be updated?
What role does post-market clinical follow-up play in clinical evaluation?