The ASTM (formerly the American Society for Testing Materials, currently ASTM International) is an organization that develops and publishes consensus technical standards...
Many factors affect the safety, suitability, and efficacy of the various medical devices used every day in the healthcare setting. Flexible medical devices are utilized...
Developing and commercializing a new product is an exciting and dynamic process. Unfortunately, more products fail to launch than actually do launch and many times this...
The FDA regulatory pathway for Premarket Notification 510(k) is required by anyone who intends to market a Class I, II, or III device in the United States intended for...