A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of Devices. From 10-1-12 to 9-30-13 approximately 1099 device 483’s were issued and a total of 4393 citations were referenced. This is approximately the same number of 483’s that were issued in 2012 (N=1090), however the number of citations referenced in […]
As posted in the Federal Register today (March 14, 2019) closes the comment period on CDRH – Recognized Standards. Once finalized, this document will list all the CDRH – Recognized Standards as FDA recognized consensus standards and will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Excerpt from List […]
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.
