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.
Much of this involves communicating with your customer, and doing it often.