Product Development
A new medical device starts as an idea or significant improvement to an existing product. But before market entry, new ideas need to be tested.
QbD is your competent partner to bring your ideas to the market.
Testing new ideas
Depending on the device type, different pre-clinical/biocompatibility tests and clinical trails need to be carried out.
These tests are to ensure that devices placed on the market and put into service do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.
QbD’s life science experts will support on all required tests.
How we support you
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ISO 10993 Biocompatibility testing:
Choose the right tests for your product as outlined in ISO 10993 based on the chemical composition of your product, conditions of exposure and the nature, frequency and degree of exposure -
ISO 14155-1 Clinical Investigation – part 1 general requirements:
Make sure that you choose appropriate tests for your product based on ISO-14155-1 -
ISO 14155-2 Clinical Investigation – Part 2 Clinical Investigation Plans:
Develop appropriate clinical plans -
Test of Literature review:
Help you decide whether to go for testing or to meet the requirements via bibliographical references
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.