Compliance

Accreditations &
Certifications.

Our QA team regularly updates documentation and policies to ensure full compliance with international regulations.

ISO 9001:2015

ISO 9001:2015

Quality Management System

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ISO 13485:2016

ISO 13485:2016

Medical Devices Quality Management System

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ISO 14971

ISO 14971

Risk Management for Medical Devices

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All certificates are issued by accredited bodies and are available for download. Our quality management system is audited annually to maintain compliance with ISO 9001, ISO 13485, and ISO 14971.