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  14th December 2018   









Clinical EvaluationSoftwareEU MDREU IVDROrthopedicsEasy Medical Device (Blog)Implementation Model for Medical Devices Regulation Guide







List of US FDA Recognized Consensus Standards Panel have been updated per FDA modifications. USA CFR Title Subchapter H has been updated following the CFR notifications. SEE ALL UPDATES

   Coming Soon:



EU GDPR, Australia, and Canada

TOPRA (Regulatory Organisation) 

 Courses and Events updated with new content. Search or Open

Easy Medical Device  (Blog) 

 New article added regarding 3D Printing. Search or Open


   EU Medical Devices Regulation 2017/745 + Imp. Acts  Open
   EU In Vitro Medical Devices Regulation 2017/746 + Imp. Acts  Open
   EU Guidance (MDCG, EU Commission, and more)  Open
   US CFR Title 21 Subchapter A & H  Open
   US FDA Guidance  Open
  AUS TGR Medical Devices Regulation  Open
  CAN Medical Devices Regulations 98-282  Open


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