Featured Product In Submissions and Approvals
FDA Oversight of Laboratory-Developed Tests — The Impact of the Final Rule
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Learn from a prominent regulatory expert how to optimize your LDT applications to help secure a 510k clearance or premarket approval. Read More
Submissions and Approvals
Devicemaker’s Guide to the 21st Century Cures Act: Changing the Face of Medical Device Regulation
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Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports
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