Clinical Affairs: about the clinical application of your medical device
Clinical Affairs covers all aspects of clinical application of your medical device.
Even before you start developing a product, literature should be researched systematically in the scope of clinical evaluation to ensure that known risks of similar products on the market may be excluded for your product. These search results are then seamlessly integrated into your product development requirements. During the course of the further development process, a final clinical evaluation record is created and filed as a central document for technical documentation; it is an obligatory prerequisite for CE certification.
Due to our long-term experience with a diverse variety of products, we quickly find the appropriate strategy for your clinical evaluation. The result: an accelerated development process and a safe and efficient medical device for your company.
The product is on the market, clinical evaluation is all done? No, because as the manufacturer, you must ensure a safe and efficient product throughout the entire product life cycle. There are different possibilities to define suitable post market clinical follow-up (PMCF) activities in the scope of post-market surveillance (PMS), such as evaluating defined questions with a large number of patients, long-term observation of patients, or investigations about known risks in literature. Based on this data you identify rare problems of your product, eliminate them at an early stage and thus increasingly adapt your successing products to your users' needs.
Involve us in your study planning and realization processes at an early stage and benefit from our know how in the fields of clinical evaluation and clinical monitoring: We find the solution that suits you best, realize it promptly and in accordance with applicable regulations, and are a competent partner for you and the test authorities at any time.
Our services in this field
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"Safety and efficiency are the decisive components for your product. We are the partner at your side for realizing this aim."