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Latest release: August 2017New regulation update on audit and certification

Medical Device Usability: Highlights of European Regulations and Standards

On November 1999, the Institute Of Medicine published “To Err Is Human”, a report analyzing the mortality of people in hospitals in the United State (up to 98000 deaths) as a result of medical errors, laying out strategies to “reduce preventable medical errors”. As per this report, medical errors, more commonly “are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them.”

If a device is difficult to use, or the instructions are not understandable for the user, device is more likely to be used incorrectly.  Poor design of medical devices and specifically poor user interface design can lead to errors that can deter patient treatment, diagnostic or monitoring and in some cases can result in harm or death; examples such as administration of incorrect medication or dose, incorrect interpretation of data resulting in misdiagnosis and also incorrect device setting for therapy are proofs of poor user interface design.

 

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 Miscellaneous

 

MDSAP Medical Device Single Audit Program

 

CE

 CE marking / European Medical Device Regulations

 

> CE marking for IVD Devices

 

ISO Quality Management System (QMS)

 

Worldwide regulation

 Worldwide Regulations

Brazil 

Russia 

Mexico 

USA 

 

 

 

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Due to rapid growth in North America, we're seeking Lead Auditors, Medical Device Clinical Expert, Production Coordinator , Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.