(medical devices and components)

Animal Tests
Qmed Consulting ApS offers support in the development phase assisting you with research, and by identifying, preparing and performing relevant pre-clinical animal test(s) in accordance with ISO 10993 and US GLP regulations.

Biological Safety and Performance
Qmed Consulting ApS and our network of experts will assist you through pre-clinical studies and in the evaluation of biological safety and performance. Additionally we set up and evaluate biocompatibility tests.

Strategy and Design
We set up your pre-clinical study strategy and design. We manage your pre-clinical tests, work out your protocols based on available scientific literature reviews and we complete your final reports with the purpose of showing product safety and performance.

Testing Sites and Sample Sizes
We assist you in finding suitable sites for your testing.

In our network we have experts who will assist you when calculating proposals for sample size for your testing and set up your statistical plan.
All services can be provided as stand alone or full package.