The market success of every medical device is based on one foundation: clinical evidence. Now you can put the planning and generation of this data in the hands of experienced experts.
With the new medical device regulation, clinical evidence is becoming a must-have.
It ensures that a medical device is safe and provides the intended clinical benefits. With accurate data you ensure your market success and your products are used effectively, delivering the desired benefits to patients.
Third-party experts are needed to generate clinical evidence. We know how.
- Clinical claim validation
- Safety and efficacy of the device
- Promotion & medical marketing
- CE mark support
- Performance monitoring and PMCF investigation
Aiming for results beyond convention.
Our proven and tested process efficiently covers all regulatory requirements. With our underlying expertise we ensure that the results are better compared to using conventional methods.
- Assessment and idea
- Monitoring and analysis / reporting
Ensuring post-market success.
Having the entire life cycle of a medical device in mind, we ensure post-market clinical follow-up (PMCF) and support your market success by using real-world data.
The generation of clinical evidence should be in line with the well-established international guidelines. Through our links you will find all the relevant information.
The fastest way is to ask us directly.
Contact us for a free case study or advice on your product life cycle.