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. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. Rob was a senior manager at several medical device companies-including the President/CEO of a laparoscopic imaging company. ![]() ![]() He is a graduate of UConn in Chemical Engineering. Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage. ![]() Additional Resources for 510k submissions
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