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ISO 13485:2016 Medical Devices QMS

Accredited ISO 13485:2016 certification (Medical Devices QMS) with Cetonix — internationally recognized, impartial and straightforward.

ISO 13485:2016 specifies requirements for a Quality Management System for organizations involved in the design, production, installation and servicing of medical devices.

It is the internationally recognized benchmark for medical device quality and is often a regulatory requirement for market access.

What the standard covers

Regulatory and customer requirements
Risk management throughout product realisation
Design and development controls
Traceability and device history records
Corrective and preventive action (CAPA)

Key benefits of certification

Meet medical device regulatory requirements worldwide
Improve product safety and quality
Enable access to global markets
Reduce risk across the product life cycle
Build trust with regulators and customers

Who is it for?

ISO 13485 is for organizations that design, manufacture, install or service medical devices, and their suppliers.

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