Robert Packard

Rob Packard is a regulatory consultant with 30+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn with a degree in Chemical Engineering. Robert was a senior manager at several medical device companies, including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, including implants and drug/device combination products for CE marking, Canadian medical device, and 510(k) submissions. The most favorite part of his job is training others.