ISO 13485:2016 Medical devices

ISO 13485:2016 Medical devices.

ISO 13485:2016

ISO 13485:2016 states the requirements for a Quality Management System (QMS), in which organizations will demonstrate their ability to provide devices needed in the medical industry and related services that need to comply with regulatory requirements and customer needs.

This standard can also be used by external parties and suppliers who supply such products and services to those organizations.

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How ISO 13485:2016 Benefits your business !

Demonstrate that you produce safer and more effective medical devices.

Increase access to more market opportunities worldwide with certification.

Commitment to continual improvement and customer satisfaction.

Capable to review and improve processes across your organization.

Increase efficiency, cut costs, and monitor supply chain performance.

Meet regulatory requirements and customer expectations.

Reducing the likelihood of longstanding issues.

Improve the organization’s credibility and image.

A standardized process to ensure consistent results.

Our Approach

ISO 13485 Development: Understanding the company processes.
Prepare Gap Analysis and Documentation.
Develop procedures according to the ISO 13485 requirements.
Training: Train key personnel for awareness training courses and internal audit training courses.
Implementation: Assist the team in the implementation of the procedures.
Internal Audit: Conduct an internal audit to ensure compliance with the requirement.
Recommend further improvements.