Navigating the World of Medical Standards and Regulations for Medical Devices



FDA Class 2 and 3 medical devices are subject to stringent regulations before being approved for the market, and the process for approval is becoming increasingly interactive, requiring more clinical and compatibility studies. Furthermore, organizations such as ASTM, ISO, AMSI and IEC have developed hundreds of different standards for medical devices and materials, which might or might not be relevant depending on the application. Selecting the appropriate standards can be difficult, but can be helpful in procuring FDA approval.

This webinar will help medical device and biomedical ceramic and glass manufacturers to understand the regulatory pathway for new product development, industry standards and their implications for applications. Topics will include:

– Navigating the regulatory framework for medical grade ceramic and glass and medical device product development
– Outlining industry standards and how they can be utilized to optimize product development
– Examining the implications for material manufacturers and medical device manufacturers

Ad Reference ID: 778588f76eb26b72

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