Ceramics Expo has announced a new webinar, ‘Navigating the World of Medical Standards and Regulations for Medical Devices’, that will take place on Thursday, February 23, 2017 at 1 PM (EST) / 18.00 GMT. Duration will be around one hour and audience members are invited to arrive fifteen minutes in advance of the start.
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, organisations 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, including those using Ceramic Injection Moulding technology, 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 utilised to optimise product development
- Examining the implications for material manufacturers and medical device manufacturers
Confirmed speakers are Gary Fischman (Principal, Future Strategy Solutions) and Dr Steven Jung (CTO, Mo-Sci Corporation). Additional speakers will be announced in due course.