We support you with longstanding experience in all tasks that result from Annex XIV of the new EU Medical Device Regulation (EU MDR 2017/745) for clinical evaluations and post-market clinical follow-up for medical device manufacturers.
We offer you full service before placing your medical device on the market for the planning of the clinical evaluation, the subsequent implementation and documentation. Take advantage of our knowledge and experience in the following areas:
- Preparation and updating of a clinical evaluation plan,
- Systematic review of the scientific literature to determine the available clinical data relevant to your product and its intended purpose and identification of any gaps in the clinical evidence,
- Identification of all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device,
- Generation of any new or additional clinical data necessary to address outstanding issues,
- Analysis of all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.
We refer to the nature, classification, intended purpose and risks of your medical device, as well as the manufacturer's claims. Additionally, we offer you a clinical evaluation regarding the equivalence of technical, biological and clinical properties, should similar products be on the market.
You benefit from our experience in post-market clinical follow-up (PMCF) of your medical device. We offer professional support with the following competencies:
- Development of a post-market clinical follow-up plan for your medical device,
- Specification of the appropriate methods to determine the performance, side effects, risks and acceptability of the benefit-risk ratio or the appropriateness of the intended use,
- Consideration of the methods and procedures prescribed in the context of clinical follow-up,
- Develop a post-market clinical follow-up evaluation report,
- Identify the need for preventive and/or corrective measures in clinical follow-up.
Please feel free to contact us by mail or telephone!