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Your partner in clinical and regulatory excellence

Rely on our expertise in all areas of Clinical Evaluation, Performance Evaluation, Regulatory Affairs, Risk Management, and Quality Management for medical devices and IVDs.

Our Service
Your partner in clinical and regulatory excellence

Rely on our expertise in all areas of Clinical Evaluation, Performance Evaluation, Regulatory Affairs, Risk Management, and Quality Management for medical devices and IVDs.

Our Service
Your partner in clinical and regulatory excellence

Rely on our expertise in all areas of Clinical Evaluation, Performance Evaluation, Regulatory Affairs, Risk Management, and Quality Management for medical devices and IVDs.

Our Service
Your partner in clinical and regulatory excellence

Rely on our expertise in all areas of Clinical Evaluation, Performance Evaluation, Regulatory Affairs, Risk Management, and Quality Management for medical devices and IVDs.

Our Service
Your partner in clinical and regulatory excellence

Rely on our expertise in all areas of Clinical Evaluation, Performance Evaluation, Regulatory Affairs, Risk Management, and Quality Management for medical devices and IVDs.

Our Service
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MDR TRANSITION
Clinical evaluation

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Pro-Liance Services at a 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.


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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.


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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.

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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.


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Biological Safety (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.


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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.


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State of the Art

The State of the Art evaluation is essential for established products as well as for products under development. It identifies the risks and benefits of similar devices and medical alternatives. The State of the Art evaluation provides input for 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.


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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.

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A STRONG PARTNER

You can rely on PRO-LIANCE.

We fill resource bottlenecks.

When valuable resources are scarce, it can become a huge burden for a company to deal with complicated and lengthy processes and ensure that all norms and standards are met.
With PRO-LIANCE, you have a competent partner at your side.

We provide expert knowledge.

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.



As scientists, we know the rules.

Over the last 20 years, we have gained enormous experience in the field of medical devices. With every new project, we are driven by a thirst for knowledge, a spirit of research, and healthy curiosity—we are always eager to learn and flexibly adapt to changing regulatory requirements.

We help you solve problems.

Each medical device and each manufacturer are unique. Therefore, we come up with customized solutions, made just for you. Even challenging questions don't discourage us - instead, we work together with you to develop strategies to achieve your goals efficiently and cost-effectively.

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.

Order Info Material