FREE ON-DEMAND WEBINAR

Preclinical Testing Requirements for FDA Premarket Submissions

Preclinical testing is a critical step in bringing a medical device to market. It not only ensures the safety and efficacy of your device but also plays a significant role in gaining FDA approval. However, understanding the FDA’s requirements and knowing how to effectively prepare for and execute preclinical testing can be a daunting task.

Join us for this insightful webinar where our expert panel will demystify the preclinical testing process and provide you with practical strategies to meet FDA requirements with confidence.

Specifically, this webinar will cover:
  • Gain a clear understanding of the purpose and FDA’s requirements for preclinical testing of medical devices.
  • Identify how to determine what type of testing the FDA requires for your device's classification.
  • Explore a practical approach to preparing for preclinical testing of your medical device.
  • Leverage best practices for executing preclinical testing for your device, ensuring the collection of critical testing data.
  • Learn how to leverage critical testing data in your premarket submission to the FDA and navigate the medical device approval process.

View the On-Demand Webinar

Preclinical Testing Requirements for FDA Premarket Submissions
Who should attend?
  • Quality Professionals and Management
  • Regulatory Affairs Professionals & Management
  • Medical Device Executives
  • Product Development Engineers and Management
  • Risk Managers
  • Clinical Professionals and Management
Register Now  

Presented by

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Moderator:
ETIENNE NICHOLS

Medical Device Guru,
Greenlight Guru

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Presenter:
CHANDLER THAMES

Director of Quality,
Rook Quality Systems

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Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

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Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems.

Rook provides clients with all of the right resources and necessary tools to comply with regulations in domestic and international markets. Rook's team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class I-III devices, SaMD, and IVDs).

Visit their website to learn more.

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