Resources

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U.S. FDA Pre-Submissions

In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about U.S. FDA Pre-Submissions.

US FDA and MDSAP Inspections for Medical Device Manufacturers

Learn more about U.S. FDA medical device inspection.

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Medical Device Registration Pathway and Regulatory Requirements in the Chinese Market

In this webinar, our experts will discuss the medical device registration pathway and regulatory requirements in the Chinese market.

Overview of Japan IVD Registration

In this on-demand webinar, our Emergo by UL expert will outline the latest insights into Japan IVD registration.

Ready, Set, Moderate: Actionable Tips for Leading Usability Test Sessions

Uncover usability insights and design opportunities by eliciting valuable feedback from usability test participants.

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EU MDR PMS Including PMCF and Vigilance

In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about EU MDR PMS, including PMCF and vigilance.

Vietnam Regulatory Approval Process for Medical and IVD Devices

This chart illustrates the DMEC approval process for medical devices in Vietnam and is available for download in the Regulatory Affairs Management Suite (RAMS).

Thailand Regulatory Approval Process for Medical and IVD Devices

The Thai FDA medical device approval process explained: This process chart illustrates the approval process for medical devices in Thailand and is available for download in the Regulatory Affairs Management Suite (RAMS).

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Effective Discovery and Design Methods – A Foundation for Success

Learn how to approach early research and design to quickly build a strong foundation of usability for new development efforts.

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ISO 10993-1 and Biocompatibility

Learn more on how to conduct a biological evaluation ISO 10993-1.

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Understanding Europe’s In Vitro Diagnostic Medical Devices Regulation

Learn more about EU In Vitro Diagnostic Medical Device Regulations.

Early Communication with the FDA

Learn more about tips and other information to help you feel comfortable when corresponding with the FDA.