Navigating the FDA’s Medical Device Pre-submission Process
This presentation provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for...
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Single Use Endoscopes Critical Safety and Regulatoy Considerations for Manufacturers
The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of...
The Transfer of Medical Device and Pharmaceutical Products between Radiation Sterilization Modalities
With the growing demand for sterilization of medical devices and pharmaceutical products, the industry is increasingly looking...
What is ISO13485
In this episode, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory...