Regulatory Open Forum

I recently hired a new employee who needs a primer on the 510(k) process. Unfortunately, it is too late for me to get him into the RAPS sponsored course this week, not because he can't get into the class, but because my company won't allow last minute business travel.

There is a 3 day course in April offered by Oriel Stat A Matrix entitled, Global Product Submissions: FDA and EU Directive Rrequirements.

Has anyone here taken this class? Would you recommend it for a person that has previous 510(k) experience but has not been involved in the 510(k) process for 5 years? He mostly just needs a refresher course and an update on changes (including FDA environmental changes like "Firmware is now considered to be software") that have been made in the past 5 years.

Thank you in advance for your recommendations.

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Christopher Dodge
Aribex, Inc.
Orem UT
United States
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Chris,

If you are open to other 510(k) courses, here is something for your consideration. 

LIVE Online Seminar Series | US FDA 510(k) Drafting | Register Here

LIVE Online Seminar Series | US FDA Premarket Approval (PMA) Drafting | Register Here

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President and Principal
http://www.regulatorydoctor.com
Riner VA
United States
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Original Message:
Sent: 03-10-2014 11:29
From: Christopher Dodge
Subject: Has anyone attended the Oriel Stat Course: Global Product Submissions Course

I recently hired a new employee who needs a primer on the 510(k) process. Unfortunately, it is too late for me to get him into the RAPS sponsored course this week, not because he can't get into the class, but because my company won't allow last minute business travel.

There is a 3 day course in April offered by Oriel Stat A Matrix entitled, Global Product Submissions: FDA and EU Directive Rrequirements.

Has anyone here taken this class? Would you recommend it for a person that has previous 510(k) experience but has not been involved in the 510(k) process for 5 years? He mostly just needs a refresher course and an update on changes (including FDA environmental changes like "Firmware is now considered to be software") that have been made in the past 5 years.

Thank you in advance for your recommendations.

-------------------------------------------
Christopher Dodge
Aribex, Inc.
Orem UT
United States
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