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Qualsys customer and medical device manufacturer York Instruments have achieved certification against the requirements of ISO 13485:2016, demonstrating successful implementation and operation of a documented medical device quality management system.
After a comprehensive audit in August as part of their mission to bring their Class II magnetoencephalographic MEGSCAN medical device to market, York Instruments were given the stamp of approval by the auditor with no non-conformances.
Quality Manager Stewart Wilson commented that:
The auditor was impressed with our EQMS and the levels of control that we were able to demonstrate, so many thanks to Qualsys in contributing to our success.
We only had two observations noted during the certification audit, so a great achievement by the team!
With a robust 13485-certified system, York Instruments can demonstrate the quality and integrity of their operation as they enter the American market, with the first MEGSCAN device to be installed at the University of Texas Southwestern Medical Centre in Dallas for sports-related concussion diagnosis.
We spoke to Stewart in July about his personal approach to quality, submitting his 510(k) pack to the FDA, and why he didn't need to prepare for his 13485 audit. Watch the interview video here.
Learn how to open five international markets with a single medical device audit here.
Or boost your own 13485 journey with our free toolkit: