Rob Packard

Medical Device Academy

Rob Packard

Rob is among the first people I met when I inherited the Medical Devices Group back in 2011.

From Rob’s LinkedIn profile:
Rob Packard is a regulatory consultant specializing in 510(k) submissions and helping start-up medical device companies with quality and regulatory requirements. The most favorite part of his job is training others.

Rob has 25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including 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 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions.

Specialties: 510(k) Submissions, FDA eCopy, Public Speaking, Distance Learning, Risk Management, Design Controls, MDSAP, CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy.

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