Critical step in regulatory compliance journey completed
The team was delighted to receive our ISO 13485:2016 certificate this week, confirming our Quality Management System (QMS) has been certified as complying with the ISO 13485:2016 standard, a QMS for Medical Device companies.
A strategic deliverable, achieving and maintaining compliance with applicable regulations is a key enabler as we commercialise and deliver compelling market offerings into the global MRI market. Further development of the QMS to comply with the requirements of additional regulatory jurisdictions beyond Europe, Canada and Australia is the next priority.
Through a dedicated team effort, our existing ISO 9001:2008 QMS was upgraded, audited and certified compliant with ISO 13485:2016 within a 12-month period – an excellent effort by everyone involved!