The requirements for clinical documentation for medical devices are becoming more comprehensive and stringent. A similar development is seen for pharmaceuticals. Therefore, considering the similarities between the two industries the move towards tighter regulatory control of medical devices is not surprising. The development in the medical device industry is illustrated by the new European directives, which state that clinical evidence must be documented for all devices, including class 1. Thus, in the future increased scrutiny will be placed on the clinical evidence for efficacy and safety of medical devices.
This development is also driven by the fact that many purchasers in the market for medical devices such as public hospitals are subject to strict budgetary control. With limited resources all purchases of new medical equipment are carefully considered. In this regard, we register an increasing need for analyses that can help manufacturers elucidate and clarify for the buyer the economic benefits of the new medical equipment.
At LINK Medical Research we have the competence to assist medical device manufacturers with tasks regarding both clinical evidence documentation of efficacy and clinical safety and also analysis of health economics.
Our services for medical device include, but are not limited to:
- Clinical trials
- Regulatory document requirements
- Local Regulatory requirements
- Guidance for regulatory processes
- Health economics
- Biometrics
- Quality assurance
- Clinical evaluation reports