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.
We selected Qualsys's GRC solution as it can be operated on various platforms. We have a number of Linux users so the software had to operate under this environment as well as Windows. Qualsys have been very supportive during all phases of the project (Dave Beard in particular) and we look forward to becoming a long-term client.