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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
Regulatory Affairs
Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis – Webinar Recording/Transcript
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Medical Device Cybersecurity: Understand the Latest Developments – Webinar Recording/Transcript
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EU-MDR’s Growing Pains: Are You Current with the Latest Developments? – Webinar Recording/Transcript
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Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript
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Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript
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Medical Device Reporting: Best Practices and Common Pitfalls – Webinar Recording/Transcript
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Real-World Evidence in Medical Device Submissions: What Regulatory, Compliance & Quality Professionals Need to Know – Webinar Recording/Transcript
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Communicating Directly with Consumers on Social Media: What You Must Know About FDA and FTC Ad and Promo Rules – Webinar Recording/Transcript
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FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers
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