It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
An FDA inspection should never be confused with a notified body audit.
Entering the Japanese device market requires an excellent regulatory team.
Every company should understand the value of employing statistics to assist in running a business.
How CFDA enforces new regulations is critical to the future.
Having a grasp on which actions are necessary at various stages of the CAPA process is critical to a quality program.
Why regulatory and quality due-diligence is often overlooked.
The agency is creating a virtual center of excellence to expedite the development of combination products.
A monumental screw up, complete with bad quality, regulatory and statutory practices.
A look into the importance of high-quality software in the medical device industry.