Learning About the New Medical Device Regulations
On May 25 the negotiators of the Dutch presidency of the Council and EU Parliament reached an agreement regarding the New European Medical Device Regulations. This MedTech Summit I am attending in Brussels is the first opportunity for the agreement to be discussed and presented at an International Conference. I am presenting at the conference on risk management and I will be chairperson of the presentation streams focusing on Post-Market Surveillance and Labeling. I will be gathering information and advice from Notified Bodies, Regulators and other industry experts at the event regarding the impact and preparation needed to comply with the new regulations.
Webinar Details for the New European Medical Device Regulations
Anyone purchasing this webinar will receive a recording of the webinar and a copy of the native slide deck for $129. There will be 24 slides during the 40-minute presentation. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the New European Medical Device Regulations. If you have company-specific questions, please send me a request to set-up a private call to discuss your specific issues.
New European Medical Device Regulations Webinar available for $129.00:
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About Your Instructor
Rob Packard is a regulatory consultant with ~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. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.