PERFORMANCE EVALUATION

OUR TASK

The evaluation process includes clinical performance, analytical performance and scientific validity. This ensures that your medical device meets safety requirements, achieves the intended clinical benefit, and complies with the requirements of the IVDR.

OUR GOAL

We focus on your needs.


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


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


Do you require additional human resources?

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Are you looking for support with regulatory and clinical affairs?


Did the Notified Body reveal any deficiencies concerning your documentation?


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).

PERFORMANCE EVALUATION AT A GLANCE

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


  • 1

    Project kick-off

    First, we work with you to define the scope and strategic approach of the clinical evaluation and agree on a timeframe, including any deadlines that must be met. The exchange of all necessary information takes place.

  • 2

    Primary analysis

    In the early product development phase of the product in question, an initial evaluation is carried out according to the current state of the art. If this already exists, it is checked and updated by us.

  • 3

    Clinical Evaluation Plan (CEP)

    We then create a clinical evaluation plan (CEP), including clinical development plan (CPD), or update the existing CEP according to the lifecycle phase and update needs for your medical device.

  • 4

    Research on the state of the art in science and technology

    We search literature and guideline databases for information on the medical background, similar medical devices and medical alternatives.

  • 5

    Data identification

    We identify clinical and generated non-clinical data for your product and fully document our database searches. We also include data from clinical trials that have been conducted.

  • 6

    Assessment

    After extensive data identification and literature search, we perform data evaluation, including data extraction from scientific publications, and quality assessment (e.g., level of evidence).

  • 7

    Analysis

    Our analysis also includes evaluations regarding the relevant General Safety and Performance Requirements (GSPRs) of the medical device under evaluation, as well as grouping the data into a Body of Evidence for the device under investigation.

  • 8

    Clinical Evaluation Report (CER)

    Finally, all activities and data are summarized in a Clinical Evaluation Report (CER). During development, the CER helps to identify any data gaps and to plan clinical trials if necessary. For conformity assessment (CE marking) of the investigated product, the CER is 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 and other sources or when design changes are made is also performed.


Get in touch with our experts!


Do you have any further requests?


  • SOP update

    We show you how to align your processes and SOPs to avoid redundancies and having to collect data and perform analyses multiple times.

    Inquiry


  • GAP Analysis

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

    Inquiry


  • CRO procurement

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

    Inquiry