Medical Devices
QbD Austria helps you to bring your medical devices to European and Chinese markets.
Our experienced life science consultants support you on all regulatory and compliance matters, such as CE marking, documentation and vigilance.
⟶ we support you on all regulatory and compliance matters for your medical devices
CE Marking
CE marking signifies that products sold on European markets meet highest safety, health, and environmental protection requirements.
QbD assists you to obtain CE Marking.
Product Development
A new product starts with a great idea – QbD is your competent partner to bring your ideas to the market.
Technical File Construction
QbD helps you to construct technical files that meet the requirements of your chosen Notified Body.
Product Classification
Medical devices need to be classified, following a certain set of rules. We help your to classifiy your product and set up a strategy to obtain CE marking.
Artwork and labelling
Artworks and labels form part of the technical file of your medical device. QbD helps you getting it right.
Regulatory Intelligence
Regulations and standards may change every now and then, and manufacturers must be aware of those changes. We keep you on track.
Vigilance
QbD supports you to set up an appropriate system of vigilance and post market surveillance (PMS).
Why opt for QbD Austria?
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.