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ISO13485 : High Quality has always been our own standard. Now its official!

Martin Bruggemann
Aug 3, 2021 3:53:14 PM

We are delighted that our Medical team have been awarded the ISO13485 qualification, adding significantly more support structures and services for our Medtech clients around the world.

ISO 13485:2016 is an internationally recognised standard for a Quality Management System to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product.

Our team consistently implements improvements to our Quality Management System to ensure our customer’s innovative medical devices are safe, perform as intended, and provide a therapeutic benefit to the patient.

By receiving ISO 13485:2016 certification, our medical device team are committed to providing our customers with high-quality design innovation services that meet or exceed all specifications and regulatory requirements.

We look forward to delivering future projects for our medical clients under the rigorous QMS that is ISO13485.



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