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ISO 13485: Medical Devices Quality Management Standards

What Is It?


ISO 13485 is an International Organization for Standardization (ISO) standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This international standard specifies the requirements for organisations that manufacture, design and/or distribute medical devices and related services. It provides a useful framework for medical devices’ quality management through its lifecycle and business processes.

What Does It Do?

By implementing this internationally recognised quality management system, you will enhance your business performance and demonstrate your compliance with best industry practices and quality control.


The benefits of obtaining ISO 13485 certification can be further listed and not limited to below:


  • Increase your brand reliability by providing quality assurance

  • Gain market access and competitive edge

  • Efficient quality monitoring and controlling system

  • Improve customer loyalty

  • Build brand trust

  • Provide indicators of quality control effectiveness and strategic directions of continuous improvement


Why Choose Us?


Wiselink Medical is committed to provide reliable consultancy and efficient services with exceptional knowledge, experience and expertise. We have an international team with a pool of experts from Australia, United States, Canada, Europe and China, who have more than 20 years of industry knowledge to offer you the most efficient and cost-effective solutions.

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