Featured Product In Regulatory Affairs
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
Medical Device Cybersecurity: Latest Regulatory Developments – Webinar Recording/Transcript
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How UDI and UDI Data Can — and Must — Be Used for More Than Just Device Identification – Webinar Recording/Transcript
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Calculating Sample Size to Satisfy FDA Expectations – Webinar Recording/Transcript
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Medical Device Risk Management Tools: FMEA Does Not Equal Risk Assessment – Webinar Recording/Transcript
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Reliability Assessment for Medical Devices and Combination Products: Meeting FDA Objectives and Requirements – Webinar Recording/Transcript
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Where Design Control Meets Risk Management: A Lifecycle Approach for Medical Devices – Webinar Recording/Transcript
$287.00