Challenge: A small, direct-to-patient provider of wound supplies and compression therapy products needed assistance with an audit of its manufacturing supplier, as well as audits associated with an ongoing clinical trial.

Beaufort Solution: Beaufort conducted these audits on behalf of the company, which allowed the company to make informed decisions as a clinical trial sponsor. This client has since requested Beaufort’s additional support in developing a Quality System and assisting with its 510(k) submissions.

Date posted: October 27, 2011

Categories: Case Studies Quality Assurance & Compliance