ISO 13485:2016 (Quality Management System for Medical Devices)

 

 

 

 

ISO 13485 is a globally accepted standard for Quality Management Systems (QMS) for the medical device industry. It defines specifications for a quality management system where a company has to show the ability to provide medical products and that relevant services adequately fulfill customer needs and relevant compliance standards. It is designed and intended to be used by organisations for the design and development, manufacture, delivery, repair, and selling of medical devices.

 

 

 

 

 

 

Benefits:-

  • Demonstrate compliance with regulatory and legal requirements
  • Manage risk effectively
  • Improve processes and efficiencies as necessary
  • Gain a competitive advantage
  • Become more effective in meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business
  • Ensure compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit

     

    How would we help you attain this QMS for Medical devices?

    Steps to attain ISO 13485

    •  Understanding the company processes and developing procedures according to the ISO 13485 requirement.
    • Train key personnel for awareness training courses and internal audit training courses.
    • Assist the team in the implementation of the procedures
    • Conduct an internal audit to ensure compliance of the requirement and recommend further improvement
    • Arrange and assist during the certification audit to ensure a smooth audit process.

     

    With the 5 steps approach, the organization can attain the certification in the fastest and most effective way.

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