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                     It is a standard quality management system that covers design, development, production and sale of medical devices. The requirements of this system are used internationally, for example in Europe, Canada, Australia. The standard is based on the ISO 9001 process model and is a management system standard developed for medical device manufacturers The primary purpose of this standard is to provide universally consistent control of the medical device industry.

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Benefits of getting certified

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• Customer satisfaction from providing products that meet customer needs   continuously in terms of quality, safety and compliance with the law
• Reduced operating costs through continuous process improvement resulting in operational efficiency.
• Build relationships with stakeholders including employees, customers and suppliers.
• Complying with the law by understanding what the regulations are. How does that affect the organization and its customers?
• Improved risk management with better consistency and traceability of products and services. including the use of risk management techniques
• It is a trusted business endorsement. By having an independent agency be the auditor to certify against the accepted standards.
• Opportunity to generate more customers – especially when customers in sectors with strict regulatory requirements require a requirement for their purchase to meet this standard.