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In this page you’ll find documents and papers provided by QRT Consulting team with years of experience helping companies maintain compliance and grow their business.
QRT Class 1
Medical Device Guidance on Requirements
US FDA
Overview of Device Regulation
US FDA
Determine if your product is a Medical Device
US FDA
Product Classification Database
US FDA
Guidance for Industry on General Wellness Devices
US FDA
Device Registration and Listing
US FDA
How to Register and List a Device
US FDA
Guidance on Medical Device Classification Product Codes
EU MDR
European Medical Device Regulation
EU MDCG
Guidance notes for manufacturers of Class I Medical Devices