mdauditor.com

Meet Your Instructors

Rob is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. His specialty is regulatory submissions for high-risk medical devices, including implants and drug/device combination products for CE marking applications, Canadian medical device license applications, and 510(k) submissions. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Training others is the part of his job that he enjoys the most.

Meet Your Instructors

Matthew brings a unique background as a former Firefighter/EMT and Rope Rescue Tech with experience in OSHA and NFPA regulations. For the better part of a decade, he has worked as a Technical/Medical Writer and Lead Auditor. He holds degrees in Fire Science and Computer Forensics and Digital Investigations, graduating Summa Cum Laude from Champlain College. Matthew is also an active member of several academic honor societies, including Omicron Sigma Sigma’s Order of the Sword and Shield. His professional focus includes Human Factors Engineering, Risk Management, and Cybersecurity, with a special interest in applying Digital Forensics and Incident Response (DFIR) practices to medical technology. He combines regulatory expertise with technical insight to strengthen both product safety and organizational resilience.