How to Prepare a Medical Device CE Marking Submission
At $49, it’s like getting advice from Notified Body expert Bassil Akra and Rob Packard for $20 an hour. You can't beat that!
Note: Once you purchase, you’ll be able to return to your unique link as often as you like. You can start now, finish later, and return for refreshers, as needed.
In this timely regulatory workshop, Medical Devices Group Advisory Board member Rob Packard, clinical expert and Notified Body representative Bassil Akra will give you a step-by-step process for preparing your CE Marking submission. The timing of this workshop is critical, because the European Council and Parliament recently finalized and published the new European Medical Device Regulations.
Your workshop purchase includes Bassil's update on the new European Regulations, explaining the impact upon currently CE Marked devices and discussing the transition plan to the new regulations. Rob Packard provides an overview of the new Annex II requirements for a Technical File submission, how to manage the preparation of your next CE Marking submission, and an overview of ISO:13485.
BONUS! When you register below, you'll get immediate access to the slides and handouts as well.
Many thanks to Bassil and Rob for sharing their time and talent with the group.
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