Please contact us: +49 (0)251 978240-0

Clinical evaluation
Targeted support for your clinical evaluation: so that your clinical evidence remains consistent, technically robust and auditable.
Make an appointment

Your trusted partner for clinical evaluation

Your challenges in clinical evaluation

The safety and performance of your medical device must be clearly demonstrated through the systematic collection, appraisal and analysis of relevant clinical and non-clinical data – throughout the entire clinical evaluation process.

Inefficient processes

Clinical evaluation, PMS/PMCF, risk management and technical documentation are often created and maintained separately. This results in inconsistencies, duplication of work and regulatory risks.

Typical consequences

Claims, clinical data, risks, PMCF activities and conclusions do not fit together neatly. This makes internal reviews more difficult, delays updates and increases the risk of queries from the notified body.

Non-Conformities by Notified Bodies

The notified body asks critical questions or identifies non-conformities (e.g. on clinical evaluation, PMS/PMCF, state of the art, equivalence or benefit-risk).

Typical consequences

Time pressure, uncertainty, certification risks and high internal coordination effort. It is often not immediately clear whether only documents need to be supplemented or whether the clinical line of argumentation needs to be fundamentally sharpened.

Lack of regulatory expertise

Internal teams are often very busy or do not have the necessary depth in clinical evaluation, medical-scientific reasoning or regulatory-compliant evidence strategy.

Typical consequences

Uncertainty regarding state of the art, clinical claims, equivalence, PMCF justification, clinical data assessment, benefit-risk argumentation and the question of what evidence is actually sufficient for a device.

Lack of review for internal / AI documents

Clinical evaluation documents are often created internally, by junior teams, external writers or with AI - often without an experienced expert review to ensure that the content is robust.

Typical consequences

Formally structured, but clinically weak (unclear claims, superficial state of the art, inconsistent content between CER, PMS/PMCF and risk management as well as insufficiently substantiated conclusions).
ADVANTAGES FOR YOU

Integrated solutions for clinical evaluation

MORE CONSISTENCY IN YOUR CLINICAL EVALUATION FILE
We coordinate the clinical evaluation, PMS/PMCF, risk management and technical documentation - for consistent, efficiently maintained and auditable clinical evidence.
RESPOND SAFELY TO NOTIFIED BODY FINDINGS
Time pressure, uncertainty and certification risks: It is often unclear whether documents only need to be supplemented or whether the clinical reasoning needs to be fundamentally sharpened.
EXPERTISE WHEN CLINICAL REASONING IS CRUCIAL
We strengthen your team with clinical-regulatory experience - so that you can make confident decisions on CER, state of the art, claims, PMCF and benefit-risk arguments.
SENIOR REVIEW FOR INTERNAL AND AI-SUPPORTED DOCUMENTATION
We check your clinical evidence for technical robustness, MDR conformity and technical robustness - so that internal or AI-generated documents are not only complete, but also truly viable.
more info
more info

Personal. Professional. By your side. Talk to our team today

Make an appointment

Your benefit

Clinical evidence that holds up when it counts.

  • Greater consistency throughout the entire clinical lifecycle
    CER, PMS/PMCF, risk management, and technical documentation are seamlessly integrated.
  • Greater Certainty in Notified Body Assessments
    Clinical reasoning, claims, and conclusions are transparent, robust, and verifiable.
  • Supporting Internal Teams
    We provide targeted support to your resources wherever senior clinical and regulatory expertise is needed.
  • Higher-quality internal or AI-supported documentation
    We verify that your clinical evidence is not only complete but also scientifically sound.
  • Faster, More Informed Decisions
    You’ll gain clarity on critical issues related to state-of-the-art, PMCF, benefit-risk, claims, and regulatory strategy.
WHY WORKING TOGETHER WITH PRO-LIANCE

Since 2004, we have been supporting manufacturers in the clinical evaluation of a wide range of medical devices in all risk classes. These include active and non-active products, software, material medical devices, implants, combination products and products without a medical purpose.

Our strength lies in not looking at clinical evidence in isolation, but in its interaction with related processes, documents and decisions. In this way, we support you in keeping clinical evaluation consistent, technically robust and auditable throughout the entire product life cycle.

Experience across numerous product areas
We are familiar with the clinical, scientific, and regulatory issues associated with a wide variety of medical devices—from established products to innovative technologies.

Clinical and Regulatory Expertise
Our team combines scientific methodology, medical expertise, regulatory know-how, and experience in medical writing and clinical data analysis.

Structured Collaboration
We work with clear processes, proven templates, and high quality standards. At the same time, we integrate seamlessly into your existing workflows, templates, and SOPs.

Strong review view
Whether created internally, externally, or with AI support: We review clinical documentation with an experienced eye for consistency, professional reliability, and auditability.

Reliable support when things get critical

We bring calm, structure and clinical-regulatory certainty to the process in the event of complex issues, tight schedules, queries or audits.

We are there for you - flexible, solution-oriented and with the right support for your challenge.

Projekt Kick-off

Together, we determine what support is appropriate for your situation – from consistent clinical documentation, queries and non-conformities to expertise or senior review. We clearly agree the objectives, results and timeframe with you.

Consistent clinical documentation

We check existing clinical and related documents for consistency, identify gaps and contradictions and align clinical evaluation, PMS/PMCF, risk management and technical documentation in a targeted manner. We then provide support with the structured revision and clear clinical argumentation.

Support with queries and non-conformities

We analyze the queries or findings of the notified body, assess the technical cause and develop a suitable response strategy. We then provide support in revising the relevant documents and formulate robust, comprehensible clinical-regulatory responses.

Clinical-regulatory
Expertise

We complement your team with expert support in clinical evaluation, state of the art, clinical claims, equivalence, PMCF, literature research, data analysis and benefit-risk argumentation. Depending on your needs, we can take on individual work packages, accompany decisions or provide ongoing project support.

Senior review of internal or AI-supported documentation

We review internally or AI-supported clinical documents for technical quality, consistency, scientific robustness and testability. We identify critical weaknesses, make specific recommendations for improvement and provide support in the targeted sharpening of the clinical argumentation.

Clarity, certainty and auditable results

At the end of the project, you will receive the agreed results in a structured and auditable form. Together we will discuss open points, recommendations and next steps – so that your clinical documentation can be continued safely, updated in a targeted manner and used successfully in reviews, audits or examinations.

Dr. Thomas Brzoska
FOUNDER, SCIENTIFIC & CLINICAL AFFAIRS EXPERT
Florian Tolkmitt
FOUNDER, REGULATORY & CLINICAL EVALUATION EXPERT

Personal. Professional. By your side.

Contact our experts

Schedule a no-obligation consultation and receive personalized advice.

Make an appointment

What Our Customers Say

“I find the level of advice and feedback on the clinical evaluation process to be very valuable, this is where real collaboration takes place.”

Sr. Director Clinical Affairs,
World market leader in the field of industrial endoscopy

“PRO-LIANCE hat für eine Produktgruppe eine komplette klinische und eine komplette biologische Bewertung erstellt. Diese wurde exakt innerhalb der versprochenen Zeit fertig gestellt. Im Zuge der Fertigstellung waren die beiden Expert*innen sehr professionell, hilfsbereit und entgegenkommend. Die erstellten Dokumente machen einen hervorragenden Eindruck.”

Dr. Martin von Rüden,
Regulatory Affairs Manager bei QUESTALPHA GmbH & Co. KG

“PRO-LIANCE supported me very quickly and straightforwardly with an urgent project. The preparation of the clinical evaluation was of high quality and structured. We were very satisfied with the processing and were able to keep our timeline.”

Medical Affairs Manager,
manufacturer of medical devices with a focus on inhalation devices