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
Designing Secure Medical Devices: Building Cybersecurity into the Development Process
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Statistics and Data for Regulatory Professionals and Attorneys: Product Performance Evidence Made Easy – Webinar Recording/Transcript
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Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success – Webinar Recording/Transcript
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The Biden Administration’s FDA: A Remarkable 2021, What to Expect in 2022 – Webinar Recording/Transcript
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Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review – Webinar Recording/Transcript
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Promoting & Marketing in the Digital and Virtual World – Webinar Recording/Transcript
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Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript
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