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ISO 13485:2016(MDQMS)

An ISO 27001 Standards Is Internationally Recognized By Medical Devices Quality Management System (MDQMS) Which Helps An Organization To Demonstrate Its Ability To Provide Medical Devices And Related Services That Consistently Meet Customer And Applicable Regulatory Requirements.

Such Organizations Can Be Involved In One Or More Stages Of The Life-cycle, Including Design And Development, Production, Storage And Distribution, Installation, Or Servicing Of A Medical Device And Design And Development Or Provision Of Associated Activities (e.g. Technical Support). ISO 13485:2016 Can Also Be Used By Suppliers Or External Parties That Provide Product, Including Quality Management System-related Services To Such Organizations.

Benefits Of ISO 13485:2016:

·    Faster Cycle Times.
·    Less Waste.
·    Systematic Process Improvement.
·    Higher Customer Satisfaction
·    Higher Prestige.
·    Simplifies Third-party Vendor Reviews
·    Increase Efficiency, Cut Costs, And Monitor Supply Chain Performance.
·    Gaining Market Share And Enhancing Reputation
·    Increase Access To More Market Worldwide With Certification.
·    Promotes Customer Retention And Accomplish New Business
·    Demonstrate That You Produce Safer And More Effective Medical Devices.
·    Outline How To Review And Improve Processes Across Your Organization.
·    Obey With Regulatory Requirements And Customer Expectations.


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