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Medical device documents elaboration

Is there a need in any medical device document? You can count on us!

Medical device industry is one of the most scence-driven field. Development of new medical devices should be done by professionals with both technical and medical background. We will help to turn your idea into a mass-produced medical device. 

Our high quality personnel (professional engineers, health care specialists, economists, analysts, marketing specialists, etc.) and cooperation with leading universities and industrial enterprises allows MEDITEX to successfully solve the task of developing documentation for medical devices!

Most popular executed orders:

• technical file
• risk management file
• manual / instruction for use
  
• product specifications

At your request, any documentation would be developed:

• medical and technical requirements for medical device
• draft project documents
  
• technical project documents
• working design and technological documentation for the prototype manufacturing (pilot batch)
• working design and technological documentation
• technological regulations
• industrial regulations for device production
• acts according to the requirements of GOST R 6.30
  
• scientific and technical reports in accordance with the requirements of GOST 7.32-2001 "Report on research work. The structure and rules of execution".

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