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Companies bringing medical devices on the market are obliged to have an appropriate system of vigilance and post market surveillance (PMS) in place.

QbD help you to set up your system.


Incidents to be reported:

  • Any malfunction, failure or deterioration in the characteristics or performance of a device
  • Any inadequacy in labelling or the Instructions for Use (IFU)
    – which directly or indirectly lead to or may have led to the death of a patient or user or of another person, or lead to a serious deterioration in their state of health.
  • Any technical or medical reason which may have lead to a batch recall of other similar devices.

How we support you

Why opt for the QbD Group?


10+ years of experience

Benefit from our team of highly qualified consultants.

Full life cycle support

Full support from pre- to the post-marketing phase.

Global presence

QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.

Customer satisfaction

Constant evaluation, transparency and clear objectives.

Contact us

Talk to an expert

Contact us for more information or to request a free, no-obligation proposal.