Amplexor transitions to ISO 13485:2016 for Medical Devices - Quality Management Systems

23 May 2019

Amplexor has recently transitioned to the new version of ISO 13485. The standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Amplexor Life Sciences is certified to the ISO 13485:2016 standard as a Global Content Service Provider to ensure the quality, safety and effectiveness of our services in the lifecycle of medical devices.

This certification demonstrates Amplexor’s commitment to provide high-quality services though process excellency, upholding business standards and continued learning and improvement.

Check here to learn what other ISO standards Amplexor is certified in