As a regulatory director, what IVDR transition milestones would you set for the end of 2020?

In the initial IVDR audit, they will be looking at your entire Quality Management System, so you must make sure that our QMS is almost done. Also, have your product submission cadence sorted by going through products and sorting them by priority, especially understanding what your high-risk products are so there are no surprises. You should also have your contract signed with your notified body, all your devices classified, and your audit on the schedule. Lastly, have your PRRC identified.

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