Vigilance
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
- Prepare for vigilance systems audits
- Implement a vigilance system in your company
- Assess your SOPs
- Write vigilance SOPs
- Help you with setting up a functioning PMS
Why opt for the QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
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.