CLINICAL EVALUATION

OUR TASK

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.

OUR GOAL

We focus on your needs.


Do you need an updated Clinical Evaluation according to current regulations?


Has the Notified Body revealed any deficiencies concerning your documentation?


Are you planning to obtain a CE-mark for your medical device for the European market?

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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

We have been working in the field of Clinical Evaluation since 2004. Benefit from our years of experience.


We use templates which have been developed based on our experience with clinical evaluation according to MEDDEV 2.7/1 Revision 4 and adapted to the requirements of Regulation (EU) 2017/745 as well as MDCG 2020-1, MDCG 2020-5, MDCG 2020-6 and MDCG 2020-13. However, we will also work using your own SOPs/templates on request.

Our team meets all MEDDEV 2.7/1 requirements for Clinical Evaluation authors: research methodology, including clinical trial design and biostatistics as well as scientific information management or a qualification in librarianship; experience with relevant databases such as Embase and Medline; regulatory requirements in medical writing, e.g. experience in a relevant natural sciences or medicine; training and experience in medical writing, systematic review and clinical data analysis.

Our consultants also have product-specific expertise, such as medical device technology and its application; diagnostics and assessment of medical device functionality, knowledge of medical alternatives, treatment standards and technology (e.g. specific clinical expertise).

CLINICAL EVALUATION AT A GLANCE

We individually tailor the scope of our clinical evaluation activities to your needs.


  • 1

    Project Kick-off

    First off, we will define the scope and strategic approach of the Clinical Evaluation. We will agree on a timeframe, including any deadlines that must be met. In this phase, we will exchange all necessary information.

  • 2

    First analysis

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

  • 3

    Clinical Evaluation Plan (CEP)

    Next, we will create a Clinical Evaluation Plan (CEP), including a Clinical Development Pan (CPD). Alternatively, if necessary, we can also update your existing CEP according to the lifecycle phase of your medical device.

  • 4

    Research of Sate-of-the-Art in science and technology

    In this phase, we will perform a thorough search on medical background, similar devices and medical alternatives in medical literature and guideline databases.

  • 5

    Data identification

    We will identify clinical and non-clinical data as well as data from relevant clinical device and fully document all our database searches.

  • 6

    Assessment

    Following the data identification phase and extensive literature search, we will evaluate the data we have found, which includes data extraction from scientific publications and quality assessment (e.g. level of evidence).

  • 7

    Analysis

    Our analysis includes the evaluation of all data according to the relevant General Safety and Performance Requirements (GSPRs) of the medical device, as well as grouping the data into a Body of Evidence for your device.

  • 8

    Clinical Evaluation Report (CER)

    Finally, all activities and data will be summarized in a Clinical Evaluation Report (CER). During device development, the CER helps to identify data gaps and plan necessary clinical trials. For conformity assessment (CE marking) of the device, the CER must be updated and sufficient data must be available to demonstrate safety and performance. An (annual) update of the CER to include new data from PMS/PMCF activities and other sources, or when relevant changes are made to the design of the device, will also be performed.


Get in touch with our experts!


Do you have any further requests?


  • Regular CER Updates

    Depending on your risk category, we can help you perform the required updates for your Clinical Evaluation – whether it be annually, for implants and or Class III devices, or every 1-5 years for your other medical devices.

    Anfrage


  • GAP Analysis

    We thoroughly review your Clinical Evaluation. Depending on your individual needs, we either work with your templates or use our tried and trusted ones.

    Anfrage


  • CRO procurement

    You require a clinical trial, but who is the right partner to conduct it? We can help you select a suitable CRO and provide advice and support during the clinical trial.

    Anfrage