Getting to market with an electronic quality system

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.

 

Issue Manager is a really flexible platform and I really enjoyed setting it up. It's nice and tightly controlled. Very auditable.

Stewart Wilson – Quality Manager, York Instruments

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