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  • I think the main hurdle will be getting an NB to renew the CE certification.  If you can work with the same NB that issued the expiring certificate, renewal will almost certainly go faster than if you go with a new NB.  A new NB may want to re-review some or all of the documentation that the original NB reviewed, and may not come to all of the same ...

  • Able to comply is one thing; comply is another.  It's the CAs that will assess their compliance, right?  I don't think we can address the "stay in business" part until we see what the CAs are prepared to accept as compliance.  Of course, due to lack of transparency, we won't be able to see that. ------------------------------ Julie Omohundro, ex-RAC ...

  • Congratulations on your achievement.  I will echo what others have said and try to discuss the possible opportunities with your manager and the RA department if you have one.  I think the best place to start is writing up information required for submissions.  Perhaps you can be the one in your department to write sections of the submissions?  In our ...



Martha Brumfield Discusses Her Regulatory Career Path

"In addition to professional enrichment, the job of a regulatory professional is personally fulfilling. While our work may be separated from the clinics and doctors' offices where the products we support are used, in the back of every regulatory professional's mind is the knowledge that the work helps people live healthier lives. Every step of the way, we are fighting for patients."" 

Martha Brumfield, PhD 

 

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