PERFORMANCE EVALUATION
YOUR TASK
The Performance Evaluation process includes the evaluation of the scientific validity, analytical performance and clinical performance. This ensures that your in vitro diagnostic (IVD) meets safety requirements, achieves the intended clinical benefit and complies with the requirements of the IVDR.
YOUR challenges
We focus on your demands.
Do you need an updated Performance Evaluation according to current regulations?
Have you been confronted with deficiencies by the Notified Body?
Are you planning to obtain a CE-mark for your IVD for the European market?
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 conduct the Performance Evaluation of your IVD in accordance with the requirements of the IVDR to achieve conformity.
Our long-standing regulatory experience in the Medical Device industry allowed us to develop high-quality templates for Performance Evaluation in accordance to Regulation (EU) 2017/746.
We are also happy to work with your own SOPs and templates on request.
Our team meets all the requirements for Performance Evaluation authors: scientific writing, good clinical practice, data analysis and safety surveillance. Our authors have experience in relevant natural sciences and medicine, e.g., in vitro assay development, biostatistical data analysis, and research methodology.
We are also experienced with extracting information from relevant scientific databases and systematically review and analyze the data.
Our consultants have specific expertise in the areas of biochemical assay development, oncology, microbiology, molecular genetics and their applications in diagnostics such as biomarker detection and drug testing. Moreover, we have an in-depth understanding of standard treatments, medical alternatives, and new technologies.
PERFORMANCE EVALUATION AT A GLANCE
We individually tailor the scope of our Performance Evaluation activities according to your needs.
1
Projekt Kick-off
Together we establish the scope and strategic approach of your Performance Evaluation. We will determine a timeframe that respects your milestones, desired outcomes and deadlines.
2
Performance Evaluation Plan (PEP)
We first create a Performance Evaluation Plan (PEP), including means of determination of the scientific validity, the analytical performance and clinical performance. We can also update an existing PEP of your IVD.
3
Research on the State-of-the-Art in science and technology
We search the literature and guideline databases for up-to-date information on the medical background, similar IVDs, and diagnostic alternatives.
4
Data identification
We identify clinical and non-clinical data for your IVD and fully document our database searches. We also include data from clinical performance studies that have been conducted.
5
Evaluation
After extensive data identification, we perform data evaluation, including data extraction from scientific publications, and quality assessment (e.g., level of evidence).
6
Analysis
Our analysis also includes evaluations regarding the relevant General Safety and Performance Requirements (GSPRs) of your IVD, as well as grouping the data into a body of evidence.
7
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 necessary clinical performance studies. For conformity assessment (CE marking) of your IVD, the PER has to contain sufficient data to demonstrate scientific validity, analytical performance and clinical performance.
Contact our experts!
Do you have any further requests?
CRO procurement
You require a clinical performance study - but who is the right partner to conduct it? We can help you select a suitable CRO and provide advice and support during the study.
Inquiry
Training
Would you like to increase your level of expertise?
Our trainings are conducted by our Clinical & Regulatory experts aiming to tailor the training to your needs, your IVD and the knowledge level of your team.
Inquiry
GAP Analysis
Before submitting your application to a Notified Body let us perform a complete GAP analysis of your Performance Evaluation.
Inquiry