Mark Vordtriede

OLYMPUS DIGITAL CAMERAMark has more than 20 years of experience with quality systems and regulatory processes. He has an Engineering degree from Washington University in St. Louis and has held Director and Vice-President level positions in quality and manufacturing.

As a consultant, Mark has helped small and large clients implement effective quality systems in the medical device, biotech, manufacturing, aerospace, and automotive sectors.

Mark has regulatory experience with ISO 13485, MDR 2017/745, CMDR SOR 98-282, PPE 89/686/EEC, and FDA 21 CFR 820. He has developed MDD technical files for CE Marks.

Mark is an Exemplar Global (EG)-certified Lead Auditor for ISO 9001 and ISO 13485. He is qualified to teach EG-certified ISO 9001 and ISO 13485 Internal Auditor and Lead Auditor courses. He has also taught courses on QSIT, GMP, CE Mark, Problem Solving, Corrective Action, Process Validation, and Design and Development.