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Hello William Coulston For convenience kitting in the US, best to keep all labeling intact as provided for each item without change and all required component labeling should be included as part of the kit. We do not recommend any labeling changes to individual kit components (e.g. to consolidate labeling, etc. since these types of labeling ...

Join us on Friday 25-September-2020 from noon to 1 pm Eastern time for your RAPS Ontario Chapter virtual kick-off Networking Lunch ! During this networking session, we will introduce your RAPS Ontario Chapter mission and plan for the year and we will play a little Kahoot game. It is advised to download the Kahoot app on your computer or your smartdevice ...

My condolences. :) I'm very old school when it comes to clinical studies, so I would never even think of using EDC for a study this small.  Maybe not a CRO, either, but you didn't ask about that. What kind of study is this? EFS, pivotal, to support clearance, labeling change/new marketing claims?  IDE? Abbreviated IDE?  ISO 14155?  How many sites? ...

I think it is often one of those pay me now or pay me later situations.  In the rush to get the 510(k) submitted, so much easier and quicker to sign the statement than to prepare a well-crafted summary to include in the submission.  But then the company is stuck with responding to requests forever and ever amen.  Plus I don't see how a well-crafted ...

​Thank you Richard.  Very helpful. ------------------------------ Cheryl Hergert Northridge CA United States ------------------------------