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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
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Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes, 2024 Edition
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Making the Case for Device Quality Management — Insights from FDA and Industry Experts – An FDAnews Video Presentation
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Proactive Supplier Management Using Quality Agreements – Webinar Recording/Transcript
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Medical Device Cybersecurity: Latest Regulatory Developments – Webinar Recording/Transcript
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Quality Culture: From Buzzword to Implementation and Measurement – Webinar Recording/Transcript
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