ISO 13485:2016

Get ISO 13485:2016 Certification

Obtaining ISO 13485:2016 certification involves implementing a Quality Management System (QMS) specific to the medical devices industry.

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Key Principles of ISO 13485:2016

Customer Focus: The organization must understand and meet customer requirements related to the design, development, production, and servicing of medical devices.
Leadership:Top management must demonstrate leadership and commitment to the establishment and continual improvement of the Quality Management System (QMS).
Process Approach: The organization must adopt a process approach to develop, implement, and improve the effectiveness of the QMS.
Risk-Based Thinking: ISO 13485:2016 emphasizes a proactive approach to risk management. Organizations are required to identify and address risks throughout the entire product lifecycle.
Internal Auditing: Regular internal audits are conducted to assess the effectiveness of the QMS and identify areas for improvement.

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About ISO 13485:2016

ISO 13485 is a globally recognized standard designed to ensure the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. At Digital Way Solutions we adhere to these stringent standards to provide you with products and services that meet the highest levels of quality and regulatory compliance.

Benefits of ISO 13485:2016 Certification:

We actively engage with experts, organizations, and governments worldwide, fostering a collaborative environment for the development of impactful global standards.

Choose us as your trusted partner in achieving excellence, as we navigate the future of standardization together, driving positive change on a global scale.