York Instruments designs and manufactures groundbreaking magnetoencephalographic (MEG) brain scanning equipment. MEG is entirely non-invasive, using sensors to precisely localise and diagnose biomagnetic brain function.
Formed in 2016, York Instruments started out managing processes and documents using spreadsheets and paper. Quality Manager Stewart Wilson realised an electronic quality management system would simplify:
- FDA 21 CFR Part 820 compliance and 510(k) submission
- ISO 13485 certification
- CE marking
To support their software teams, it was vital that the new solution was Linux-compatible: York Instruments replaced their paper legacy systems with Qualsys’s document and issue management modules, creating a secure electronic document repository and adding layers of control and automation into the design and development process.
It's thanks to EQMS that we were able to demonstrate our controls, our documentation, our process flows. It's all held within EQMS and the ISO 13485 auditor liked that.