SERVICES
Pro-Liance Services at glance
We help you to launch your medical devices and IVDs quickly and efficiently.
Clinical Evaluation (CER)
During Clinical Evaluation, we collect, appraise, and analyze all relevant data around the clinical use of your medical device. This proves the safety and performance of your product and demonstrates that it meets the intended purpose and clinical benefit.
Performance Evaluation (IVD)
The evaluation process for in vitro diagnostics includes clinical performance, analytical performance, and scientific validity. This ensures that your IVD achieves the intended clinical benefit and complies with the requirements of the IVDR.
PMS / PMCF
We develop appropriate Post-Market Surveillance strategies and conduct suitable activities to monitor the use of your medical device in the market. This way, we can verify the performance of your product and ensure increased safety of your medical device by identifying unknown risks.
Quality Management (QM)
As a manufacturer of medical devices, you must develop, implement, and maintain a QM system in accordance with MDR and IVDR. Depending on its risk class, a certified QM system according to ISO 13485 and the requirements of MDR/IVDR is mandatory.
Biological evaluation (BER)
As a manufacturer of medical devices, it is required to ensure the biological safety of the product in accordance with the ISO 10993. Biological risks, such as the toxicity of used materials or production residues, must be minimized.
Risk Management
A carefully implemented Risk Management process can significantly improve the safety of a medical device right from the development phase. Risks arising from a product are systematically recorded and minimized through suitable measures.
State of the Art
The State of the Art evaluation is essential for established products as well as for products under development. It identifies risks and benefits of similar devices and medical alternatives. The State of the Art evaluation provides input for the Risk Management for PMS and is the basis for the Clinical Evaluation. A strong State of the Art evaluation is the foundation of a successful CE certification.
SSCP
Providing a Summary of Safety and Clinical Performance (SSCP) or a Summary of Safety and Performance (SSP) has been mandatory for manufacturers of higher risk medical devices or in vitro diagnostics, respectively, since the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) were introduced in 2017. We will support you in meeting the increased level of requirements.