Regulatory Overview of Leachables and Extractables in Flexible Medical Devices
4 minute read

Regulatory Overview of Leachables and Extractables in Flexible Medical Devices

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...

Effective Guidelines to Launch a Medical Device Product
3 minute read

Effective Guidelines to Launch a Medical Device Product

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)
6 minute read

The FDA Regulatory Pathway for Premarket Notification 510(k)

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...

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