Ombu Enterprises LLC Ombu Enterprises LLC   
 
 
 
  Medical Device Regulations
Ombu offers training and consulting in medical device regulations for manufacturers

Ombu offers training and consulting in medical device regulations for manufacturers. We focus on three geographic areas of importance to American manufacturers: US, EU, and Canada.

 

In the US the regulations extend beyond FDA QSR to medical device reporting; registration and listing; corrections and removals; unique device identification, etc.

 

In the EU the product directives (MDD, IVDD, and AIMD) govern and provide Essential Requirements supported by Harmonized Standards.

 

In Canada the Canadian Medical Device Regulations (CMDR) govern, supported by the Canadian Medical Devices Conformity Assessment System (CMDCAS).

 

Overarching the regulatory system are the guidance documents from the International Medical Device Regulators form (IMDRF).

 

 

 

 

 

 

 

 

 
 
 
 
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