The world's most well known standards for medical device quality management have been updated for the first time since 2003. Released in March by the International Organization for StandardizationISO 13485 provides the universal requirements for manufacturers and service providers to comply to regulatory requirements. The standards aim to establish consistent processes for medical device design, progression, installation and distribution, focusing on the safety of the total life span of the device.

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Some of the essential changes:

  • Globally aligning regulatory requirements
  • Applying risk management practices throughout the quality managment system
  • Attention to supplier sourcing and selection
  • Supplemental requirements for design activities, such as validation and verfication
  • More specific requirements for Design and Development, Corrective Action and other applications
  • Required Medical Device File to validate compliance to new standards 

The standards must be adopted by 2019, which could prove to be a difficult task for manufacturers. Commencing adoption sooner rather than later will aid a steady transition, and that's why we're hosting a free webinar.

 Click the image for more information and to register.

New ISO 13485 Standards for Medical Devices Webinar Graphic

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