Sunday November 19th, 2017
About Us  |  Employment Opportunities  |  Contact HRC
Home FoodDrugsBlood & BiologicsMedical DevicesImports & ExportsAnimal Food & DrugTobacco
{d3}

Medical Devices

Do the developing changes to the requirements for 510(k) submissions or a revamping of the de novo automatic Class III designation process have you worried? Rest assured, Humphrey Regulatory Consulting (HRC) is tracking potential changes to these approval pathways closely, including the possible creation of II(b) device pathways, and can help your company successfully navigate evolving CRDH requirements. With our long history and substantial expertise, HRC  can assist manufacturers, distributors and importers with compliant product development strategies covering:

     Premarket Approval Applications (PMAs)
     Premarket Notifications (510(k)s)
     Investigational Device Exemptions (IDE)
     Quality System Regulation (QSR)
     Medical Device Reporting (MDR)
     • FDA establishment inspections
     • Import/export of medical devices
     • FDA 483s and Warning Letters
     • Recalls, injunctions and seizures
     • Labeling, advertising, and promotion
     • Establishment registration and medical
        device listing requirements




 

 

 

 

Don't let compliance with complex government regulations or developing changes to the 510(k) clearance or de novo review processes throw your project off schedule and off budget. Contact one of our medical device regulatory experts today for a free consultation.

Copyright © 2017 Humphrey Regulatory Consulting Inc. All rights reserved.  |    |  Terms of Use  |  Privacy Policy

Editor Login