ISO MDQMS 13485:2016 [Medical Device Quality Management System]

ISO 13485 is an internationally published standard that outlines quality management system criteria for producers of medical devices and equipment. The primary goal of this standard is to promote standardised quality management system standards for regulatory responsibilities in the medical device sector.

ISO 13485 is a great system standard for medical device companies. It is by far the most common method of satisfying the Quality Management System (QMS). Medical equipment requirements in Europe, Canada, and Australia also serve as the foundation for QMS compliance in countries such as Japan, Korea, and Brazil.

What are the benefits of having an ISO 13485 accreditation for your company?

If you manufacture or sell a Class II or higher risk categorization equipment outside of the United Arab Emirates, you must most likely be ISO 13485 certified. ISO certification may also broaden your market access and boost your company's profitability. Here are some of the benefits of ISO 13485:

• It is the true standard for international medical apparatus QMS compliance, and it is required for access to many key markets worldwide.
• ISO 13485 certification necessitates time and work to obtain, but it gives you with more credibility with potential clients.
• An attractive QMS system promotes productivity, product quality, and customer service in your company.

What further benefits might I anticipate?

• Lower operational expenses
• Stakeholder ties have improved.
• Compliance with the law
• Risk management has been improved.
• Demonstrated business credentials
• New market opportunities
• Customer gratification

What is the structure of ISO 13485?

ISO 13485 is based on the criteria of ISO 9001 and has the same clause structure. The ISO 13485 standard, Medical devices - quality management systems – regulatory requirements, serves as the foundation for regulatory compliance in both domestic and most export markets. Certification displays your dedication to addressing the needs of your customers.

Who is eligible to apply for ISO 13485 certification?

ISO 13485 applies to all makers and suppliers of medical devices, components, contract services, and medical device distributors. To lawfully manufacture and sell medical devices in a number of areas, ISO 13485 certification is insufficient on its own. The necessary local regulatory certification is also required.

ISO 13485 Standard Requirements:

• Approach to risk management in product development and product realisation
• Process verification
• Observance of legal and regulatory obligations
• Product tracing and recall systems that work
• Implementation of a quality management system that has been enhanced in numerous ways.

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