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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
Usability Engineering: How the Updated ISO 14971:2019 Changes Your Process – Webinar Recording/Transcript
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How to Deploy Root Cause & CAPA to Minimize Human Error – Webinar Recording/Transcript
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EU-MDR: Are You Ready? An Exclusive Three-Part FDAnews Webinar Series – Webinar Recording/Transcript
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