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  14th December 2018   


  

 

  

 

  

 

  

 


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

 

 

 

Updates: 

 

 

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



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TOPRA (Regulatory Organisation) 

 Courses and Events updated with new content. Search or Open

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Easy Medical Device  (Blog) 

 New article added regarding 3D Printing. Search or Open

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   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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