Quality Management System

FDB operates a comprehensive Quality Management System (QMS) which is certified to ISO 13485:2016, a widely recognised and globally defined standard, and which is audited independently on a regular basis.

Adherence to our QMS ensures the necessary policies and procedures are in place to enable us to deliver clinical decision support products of a consistently high quality, imperative in a patient-safety driven business.

This Quality Management System is in place to ensure that we:

  • Actively work to improve the quality of healthcare to the benefit of patients and the healthcare professionals who serve them.
  • Build close partnerships with our customers so that we clearly understand their requirements.
  • Deliver high quality products and services so that customer expectations are always met and wherever possible exceeded.
  • Use customer feedback to continually improve our products and services and to bring new products and services to market.
  • Provide an open, supportive, challenging team-oriented environment within which employees can achieve job satisfaction and professional and personal growth.
  • Fairly reward all our employees and continually support them with adequate resources and training.
  • Establish objectives which will as a minimum be evaluated as part of the Management Review process.
  • Comply with all statutory and regulatory requirements.
  • Embrace and comply with ISO 13485:2016, a widely recognised and globally defined standard.


  ISO 13485:2016 logo