CLINICAL EVALUATION

YOUR TASK

The safety and performance of your Medical Device needs to be demonstrated by collecting, assessing, and analyzing all relevant clinical and non-clinical data during the Clinical Evaluation process according to Regulation (EU) 2017/745 (MDR).

YOUR CHALLENGES

We focus on your demands.

Are you planning to CE-mark your Medical Device?


Do you need an updated Clinical Evaluation according to MDR?


Has your Notified Body detected any deficiencies concerning your documentation?

Are you looking for Regulatory and Clinical Affairs support?


Do you need additional human resources?


Are you looking for external know-how and independent expertise?

YOUR BENEFITS

Since 2004, we have performed numerous Clinical Evaluations for many different types of Medical Devices of all Risk classes. Among others, this includes active and non-active Devices, software, substance-based Medical Devices, implants, combination products, and Annex XVI Devices. We have supported manufacturers at different stages of product development, from establishing the first Clinical Evaluation for innovative products to updating existing Clinical Evaluations for Legacy Devices.

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Our thoroughly developed templates align with MEDDEV 2.7/1 Revision 4, are tailored to meet the requirements of Regulation (EU) 2017/745 and comply with the guidance documents (MDCGs: MDCG 2020-1, MDCG 2020-5, MDCG 2020-6 and MDCG-2020-13). Of course, we are also happy to work with your own Standard Operating Procedures (SOPs) and templates.






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Our Clinical Evaluation authors fulfill all necessary prerequisites outlined in MEDDEV 2.7/1, including expertise in research methodology, clinical trial design, biostatistics, and scientific information management. Our authors also have in-depth knowledge of regulatory requirements, with backgrounds in natural sciences or medicine. They have undergone rigorous training and gained extensive experience in medical writing and clinical data analysis.



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Our consultants possess specialized knowledge in Medical Device technology, applications, and diagnostics. They have a deep understanding of Medical Device functionality and are well-versed in medical alternatives, treatment standards, and technological advancements. This expertise makes them true experts in their respective fields.







Customer testimonials

"

PRO-LIANCE has prepared a complete clinical and a complete biological evaluation for a product group. These were completed exactly within the promised time. In the course of the completion, the two experts were very professional, helpful and accommodating. The produced documents make an excellent impression.

"

Martin von Rüden,
Regulatory Affairs Manager at QUESTALPHA GmbH

"

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 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

CLINICAL EVALUATION AT A GLANCE

We customize the scope of our Clinical Evaluation activities to specifically align with your unique requirements.

1

Projekt Kick-off

Together we will establish the scope and strategic approach of your Clinical Evaluation. Additionally, we will determine a timeframe that respects your milestones, desired outcomes and deadlines. 

2

First analysis

In the early product development phase, an initial evaluation according to the current State of the Art will be performed. If a State of the Art document is already available, we will review and update it, if necessary.

3

Clinical Evaluation Plan (CEP)

We will create a Clinical Evaluation Plan (CEP), including the Clinical Development Plan (CPD), a specification of the intended purpose, the clinical benefits, claims, and relevant clinical outcome parameters. Alternatively, we can also review and update your existing CEP.

4

State of the Art Evaluation

We will evaluate the State of the Art for your device including the medical background and alternatives. The evaluation also includes the identification of similar devices and the quantification of benchmark parameters. Seamless integration with your Clinical Evaluation documentation will be ensured.

5

Data identification

A literature search protocol including defined inclusion and exclusion criteria will be developed. Based on this, we perform systematic and unbiased data identification, which include various scientific and medical databases as well as clinical trial registries, as required. All data identification steps in the literature search report will be comprehensively and reproducibly documented.

6

Data Appraisal

All relevant clinical data including data extraction and quality assessment according to established assessment schemes (e.g. level of evidence) will be appraised.

7

Analysis

All data will be analyzed regarding compliance of your Medical Device with all relevant General Safety and Performance Requirements (GSPRs). The Clinical Data will be collated into a body of evidence.

8

Clinical Evaluation Report (CER)

All activities and data will be summarized in a Clinical Evaluation Report (CER). Potential gaps in confirming the safety and performance of your Medical Device will be identified. Depending on the device and the lifecycle phase, those gaps can be closed by performing Clinical Investigations or PMCF activities.

Get in touch with our experts!

Do you have any further requests?

Regular CER Updates

Depending on the classification of your device, a regular update of the Clinical Evaluation is necessary: annually for implants and class III Devices, or every 1-5 years for other Medical Devices. We can help you to perform an efficient update of your Clinical Evaluation documentation.

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CRO procurement

Does your Clinical Evaluation Report conclude that it is necessary to obtain clinical data, to perform Clinical Investigations or PMCF studies? We support you!

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GAP Analysis

Before submitting your application to a Notified Body let us perform a complete GAP analysis of your Clinical Evaluation. We will used an evaluation template based on MDCG 2020-13, similar to Notified Bodies.

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Training

Would you like to increase your level of expertise? Our trainings are conducted by our Clinical & Regulatory expert aiming to tailor the training to your needs, your Medical Device and the knowledge level of your team.

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