The requirements regarding performance and clinical benefit requirements of a medical device may change at any time. We are able to support in the State-of-the-Art analysis to ensure that your product meets the high expectations of the clinical community.
Providing a Safety and Clinical Performance Report (SSCP) has been mandatory for manufacturers since the Medical Device Regulation (MDR) was introduced in 2017. We will support you in meeting the increased level of requirement.
We actively monitor the market and develop appropriate Post-Market Surveillance strategies for your medical device. Possible complications and trends can be identified early and improve the overall safety of medical devices, which are already on the market.
Based on the results of the CER, we help you plan your PMCF activities according to MDCG 2020-7. We support your data collection activities and help with evaluating the results for your PMCF Evaluation Report with a special focus on safety and performance.
A carefully-conducted risk analysis can already significantly improve a medical device's safety, as early as the development phase. Consequently, potential risks associated with the device can be recorded and minimized by taking appropriate measures.
As manufacturer you are required to ensure the biocompatibility of your product. Biological risks, e.g. materials that cause allergic reactions, must be minimized. We can help you meet the requirements according to the ISO 10993 standard.
Before market launch, your medical device must undergo a conformity assessment procedure. Depending on its class, a certified QM system according to MDD and MDR is mandatory. We will be happy to support and advise you in this regard.
The evaluation process includes Clinical Performance, Analytical Performance, and Scientific Validity. This ensures that your medical device meets safety requirements and achieves the intended clinical benefit and complies with the requirements of the IVDR.
When valuable resources are scarce, it can become a huge burden on a company to deal with complicated and lengthy processes and ensure that all norms and standards are being complied with. However, with PRO-LIANCE, you have a competent partner at your side. We are here to help you meet those requirements efficiently, so that you can continue to focus on your day-to-day business.
Whether you are a start-up needing CE marking for your first medical device or an established business in the medical device industry, you will benefit from our specific knowledge in research methodology and clinical data evaluation.
Over the last 20 years, we have built up enormous experience in the field of research and clinical evaluation of medical devices. Each new project feeds our spirit of research and curiosity – we are always eager to learn and flexibly adapt to changing regulatory requirements.
Each medical device and each manufacturer are unique. Therefore, we come up with customized solutions, made just for you. We do not get put off by tricky situations. Instead, we are happy to help you develop strategies for achieving your goals both in a time and cost-efficiently manner.
Request information material
Would you like to learn more about the approval process for medical devices? Request our Clinical Evaluation Guide as free information material.