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What is ISO-13485?

A Medical Device is any product or machine that is intended to be used in the diagnosis, prevention, and treatment of a disease or any other medical condition. 

“Safety and Quality”, are two things that can not be jeopardized in the medical device industry. So, for the organizations involved in this industry of designing, producing, installing, and maintaining medical devices, ISO 13485 was formed. ISO 13485 is an internationally agreed quality management system that sets out the requirements for quality management specifically in the medical device industry. 

Purpose of ISO 13485

ISO 13485 was developed by the International Organization of Standardization (ISO) in order to outline the standards for Quality Management Systems (QMS) that must be kept in mind while designing and developing medical products.

A survey conducted by the ISO 13485-certified organizations shows that the companies that have adopted the standard continue to show a positive trend in the market on a global level. 

What will you learn in this complete guide?

  • What is a Quality Management System?
  • What is ISO-13485?
  • Benefits and Importance of implementing ISO-13485
  • Steps to adopt ISO-13485
  • Difference between ISO-13485 and ISO-9001
  • How does Visure help ISO-13485 compliance?

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