Committed to quality

QuantuMDx is ISO 13485: 2016 certified – a quality system standard designed specifically for medical device companies.

ISO certification is the international hallmark of quality. It provides the assurance that our products have been designed and developed to the very highest quality, follow a user-centred approach and are subject to external quality reviews.

ISO certification also demonstrates:

  • a robust risk management system in place
  • our company-wide commitment to scientific and engineering excellence
  • a culture of continuous improvement.

We have a team of in-house and external regulatory specialists who are focused on ensuring we achieve our aim of securing CE-IVD certification, WHO PQ and FDA510(k) market clearance for our product portfolio.