The Matrixx Case – Analysis by Dan O’Leary (June, 2011 – 8 Pages)
Category Archives: Medical Device Regulations
Changes to QSR
Changes to QSR (December, 2010 – 6 Pages)
Understanding “Product” in FDA’s QSR
Understanding “Product” in FDA’s QSR (December, 2010 – 3 Pages)
Process Validation for Medical Devices GxP Article
Process Validation for Medical Devices GxP Article (June, 2010 – 6 Pages)
Process Validation for Medical Devices
Process Validation for Medical Devices (May, 2010 – 74 Pages)
Regulatory Requirements for Medical Device Calibration Programs
Regulatory Requirements for Medical Device Calibration Programs (April, 2010 – 73 Pages)
Determining the Revision Level of QSR Sections
Determining the Revision Level of QSR Sections (April, 2010 – 2 Pages)
Excel Spreadsheets and FDA Device Regulations
Excel Spreadsheets and FDA Device Regulations (March, 2010 – 75 Pages)
Medical Device Classification
Medical Device Classification (February, 2010 – 79 Pages)