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Your partner for Clinical Evaluation, Regulatory Compliance & Quality Management

We can help you to launch your medical devices quickly.
You can rely on our expertise in all areas of Clinical Evaluation, Regulatory Affairs, Risk Management and Quality Management.

Our Service
Your partner for Clinical Evaluation, Regulatory Compliance & Quality Management

We can help you to launch your medical devices quickly.
You can rely on our expertise in all areas of Clinical Evaluation, Regulatory Affairs, Risk Management and Quality Management.

Our Service
Your partner for Clinical Evaluation, Regulatory Compliance & Quality Management

We can help you to launch your medical devices quickly.
You can rely on our expertise in all areas of Clinical Evaluation, Regulatory Affairs, Risk Management and Quality Management.

Our Service
Your partner for Clinical Evaluation, Regulatory Compliance & Quality Management

We can help you to launch your medical devices quickly.
You can rely on our expertise in all areas of Clinical Evaluation, Regulatory Affairs, Risk Management and Quality Management.

Our Service
Your partner for Clinical Evaluation, Regulatory Compliance & Quality Management

We can help you to launch your medical devices quickly.
You can rely on our expertise in all areas of Clinical Evaluation, Regulatory Affairs, Risk Management and Quality Management.

Our Service
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Clinical evaluation

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Pro-Liance Services at a glance

We offer you an objective analysis and evaluation of your clinical data and will help you introduce your medical devices to market quickly.

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Clinical Evaluation

During the Clinical Evaluation process, we collect, assess, and analyze the clinical data of your medical device in order to confirm its safety, performance, and clinical benefit.

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State of the Art

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.

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SSCP

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.

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PMS

We actively monitor the market and develop appropriate Post-Market Surveillance strategies for your medical device. As a result, we can identify possible complications and trends early and improve the overall safety of medical devices, which are already on the market.

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PMCF

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.

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Risk Management

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.

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Biological Safety (BEV)

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.

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Quality Management (QM)

A sustainably structured and certified quality management system in accordance with ISO 13485 not only helps to control and improve your company, but also to secure it's existence in the long term.

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Performance Evaluation

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.

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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 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.

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 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.

We help you solve problems.

Each medical device and each manufacturer are different. Therefore, we create 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.

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