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ISO 13485:2016 – work with SGS to ensure a smooth transition to the latest version of ISO 13485 and demonstrate your commitment to customers.

Medical device

The globally recognized standard ISO 13485 Medical devices – Quality management systems forms the basis for regulatory compliance in local markets and most export markets. Certification demonstrates your commitment to meeting customer requirements.

ISO 13485:2016, the latest update to this standard, incorporates many changes.

We provide a wide range of solutions to help you to stay on top of the latest developments and ensure a smooth and transparent transition from your current ISO 13485:2003 certification.

How can SGS help?

We offer one-day training courses to help you to understand the requirements of ISO 13485:2016 and risk based thinking.

Our experts will carry out a needs assessment for you and provide you with an action plan to help you to comply with the new revision to the standard.

Contact us to learn more about the transition to ISO 13485:2016.