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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: submissions
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Master 510(k), IDE, and PMA Submissions at AdvaMed's Workshops
on 14 October 2016 | By Kate Keverline
Within driving distance to D.C.? There's still time to enjoy a few days there next week and simultaneously hone your submissions skills. The FDA, R&Q, and other talented industry experts courtesy of AdvaMed are offering three workshops dedicated to teaching you the guidelines...
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Submissions | Fda | Medical Device | Team Members | Regulatory | 510(K) | Approval Time | Medicaldevice | Customer Success | Collective Experience | Regulatory Professionals | Fda Clearance
510(K) Success!
on 3 June 2013 | By Ryan Kasun
RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to obtain clearance, but swell with pride because of how we obtained it.
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Quality Systems | Submissions | Guidance Documents | Good Manufacturing Practices | Fda | Biological Product | Current Good Manufacturing Practices | Combination Product | Combination Products
Would you like fries with your Combo meal?
on 31 January 2013 | By Ryan Kasun
On January 18, 2013, the FDA announced their final rule on current good manufacturing practices for Combination products. These Guidance Documents will tell companies when submissions would be required for any post-approval changes to a combination product. First off, what are...
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Medical Images | Software Developers | Submissions | Regulatory Effort | Image Viewing Software | Diagnosis | Computer File | Ipad | Regulatory Pathway | Submission | Fda | Medical Device | Image Credit | Barco | Press Release | Calibration | Medical Applications | 510(K) | Princeton | Job | Fda Clearance
Mobile Medical Applications: Visual Calibration
on 2 December 2011 | By Ryan Kasun
Our third installment of the mobile medical apps series finally features a mobile medical app. This app in particular, the MediCal QAWeb Mobile app, is used to calibrate the screen of an iPad for diagnosis of medical images viewed on said iPad (both versions 1 and 2 according to...
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