Title - Clase 12 - Mtro. David Pieratos 2.pdf ✅

BD RESTRICTED Confidential—For Internal Use Only MDSAP Overview Training Medical Device Single Audit Program David Pieratos (Trainer) March 22, 2025 : Online (9am – 2pm)
BD RESTRICTED ABOUT THE TRAINER • Over 30 Years in the Medical Device Industry. • Degree in Chemistry and Biochemistry. • Former Canada CMDCAS Auditor and TUV ESSEN/TUV NORD [EU Notified Body] Auditor and Technical Document Reviewer. • Employed at Becton Dickinson and Company since August 2005. • Designed the MDSAP Program at Becton Dickinson and Company.

BD RESTRICTED What is ISO 13485:2016 4 An internationally recognized standard; Outlines the requirements of a Medical Device Manufacturer; Designed for organizations that are involved in the design, manufacture, and distribution of medical devices; Ensures a manufacturer meets customer and regulatory demands for safety and efficacy.