Tracy P. Omdahl
Chief Quality Officer, myQualityCloud, Orlando, FL, USA

Tracy Omdahl, ASQ CMDA (and other certs) has over 40 years of experience assessing and implementing quality management systems, having participated in more than 2,500 assessments since the 1970’s. Related to the course topic, Tracy has professionally audited the entire ISO series of QMS standards since its advent in the 1987 version until today, and is intimately familiar with their history, strengths andweaknesses and transition from paper binders to cloud based QMS.USFDA GD211 Auditor, Standards Council of Canada certified CMDCAS ISO 13485 registrar assessor. CE Marking Notified Body Registrar Auditor, ASQ: CQE 11147, CPGP 58, CMQ/OE 265, CQA 434, CHA 59, CMDA 59, CBA 58, CSQE 136, CRE 1565, CQT 10079, CMI 2033, CQIA 43, CCT 49, and CSSYB 287 and CQPA 2054. ISO, QS, VDA, TL & Med Dev Auditor. Former MBNQA Examiner. myQualityCloud Master Senior Medical Device Virtual Auditor

Virtual Med Dev Audits with Google Drive

Industry is challenged with the ever accelerating rate of change of technology as it impacts the auditing profession. The industry is are currently in between the ancient paper systems and the audits being conducted remotely by Artificial Intelligences. This presentation is also a workshop to prepare those who have not yet gone to virtual medical device audits.