The FDA recently issued its final guidance intended to help the medical device industry determine applicable requirements for making a change to a medical device manufacturing site.

Continue Reading


Many FDA-regulated manufacturers find themselves without the resources or processes to efficiently manage product complaints. When the resulting backlog isn’t cleared quickly and completely, the issue can compound into serious safety and compliance problems requiring many hours of work to resolve.

Continue Reading

Corrective and Preventive Action (CAPA) routinely tops the list of most-cited inspectional observations year after year, making it a clear target for investigators. When problems are found in your CAPA program, it can open your broader QMS up to intense scrutiny.

Continue Reading