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Your competent partner for clinical and regulatory challenges

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 competent partner for clinical and regulatory challenges

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 competent partner for clinical and regulatory challenges

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 competent partner for clinical and regulatory challenges

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 competent partner for clinical and regulatory challenges

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

Our Hot Topics:

Clinical Evaluation
PMS/PMCF

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Florian
Pro-Liance Services at a glance

We support you in bringing your medical devices and IVDs
to market quickly and efficiently.

Clinical evaluation (CER)

During the clinical evaluation, we collect, assess and analyze the relevant data relating to the clinical use of your medical device. This proves the safety and performance of your medical device and demonstrates that your product fulfills its intended purpose and the promised clinical benefits.

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PMS / PMCF

We develop appropriate post-market surveillance strategies and carry out suitable activities to monitor the use of your medical device on the market. In this way, we can check the performance of your product on the market and ensure increased safety on the market by identifying unknown risks.

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Risk Management

Carefully implemented risk management can significantly increase the safety of a medical device right from the development phase. Risks emanating from a product are systematically recorded and minimized through suitable measures.


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Biological safety (BER)

As a manufacturer of medical devices, you are obliged to ensure the biological safety of your product in accordance with ISO standard 10993. Biological risks, such as the toxicity of materials used or production residues, must be minimized.



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State of the Art

The assessment of the state of the art is essential for both established products and products under development. It identifies the risks and benefits of similar products and medical alternatives. A sound assessment of the state of the art is the basis for successful CE certification.


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Performance evaluation (IVD)

The performance evaluation for in-vitro diagnostic devices includes clinical performance, analytical performance and scientific validity. This ensures that your IVD achieves the intended clinical benefit and meets the requirements of the IVDR.



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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 the MDR and IVDR. Depending on the risk class, a certified QM system in accordance with ISO 13485 and the requirements of the MDR or IVDR is mandatory.




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SSCP

Since the introduction of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) in 2017, manufacturers of medical devices and higher-risk in vitro diagnostic medical devices must prepare a Summary of Safety and Clinical Performance (SSCP) or Safety and Performance Summary (SSP). We support you in meeting these 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 be 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 company requiring CE marking for your first medical device or an established company in the medical device industry, as an experienced service provider for regulatory issues, we offer you specific knowledge of research methodology and clinical data evaluation.

As scientists, we know the rules.

Over the past 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 never stop learning and adapt flexibly to changing regulatory requirements.

We help you solve problems.

Every medical device and every manufacturer is unique. Therefore, we create customized solutions, made just for you. Even tricky questions don't scare us off - instead, we work 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.
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