PERFORMANCE EVALUATION

OUR TASK

The evaluation process includes clinical performance, analytical performance and scientific validity. This ensures that your in vitro diagnostic 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 Performance Evaluation according to current regulations?


Are you planning to obtain a
CE-mark for your IVD 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 are ready to implement the IVDR. We have all the skills and competencies to support your IVDs under the IVDR.


Our long-standing experience with the Regulation (EU) 2017/745, which is quite similar in structure, content, and requirements to the Regulation (EU) 2017/746, allowed us to develop high-quality templates for Performance Evaluation. However, we will also work with and improve your own SOPs and templates on request.

Our team meets all the requirements for Performance Evaluation authors: scientific writing, good clinical practice, data analysis, safety surveillance, and plain language writing. Our authors have experience in relevant natural sciences or medicine, e.g., in vitro assay development, biostatistical data analysis, and research methodology. We are also experienced with extracting information from relevant scientific databases such as Embase and Medline and systematically review and analyze the data.

Our consultants have product-specific expertise in biochemistry, oncology, microbiology, and molecular genomics and are experienced in its application for diagnostics such as biomarkers and drug testing.

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 Performance 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 development phase of the product in question, an initial evaluation is carried out according to the current State-of-the-Art. If it already exists, we will review and update it.

  • 3

    Performance Evaluation Plan (PEP)

    We then create a Performance Evaluation Plan (PEP), including a clinical performance study plan, or improve the existing PEP according to the lifecycle phase and update needs for your IVD.

  • 4

    Research on the State-of-the-Art in science and technology

    We search the literature and guideline databases for information on the medical background, similar IVDs, 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 IVD under evaluation, as well as grouping the data into a Body of Evidence for the IVD under investigation.

  • 8

    Performance Evaluation Report (PER)

    Finally, all activities and data are summarized in a Performance Evaluation Report (PER). During development, the PER helps to identify any data gaps and to plan clinical trials if necessary. For conformity assessment (CE marking) of the investigated product, the PER is updated and sufficient data must be available to demonstrate safety and performance. An (annual) update of the PER 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