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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 medical device 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?
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. In-depth knowledge of medical alternatives, treatment standards and new technologies (e.g. special clinical expertise in the relevant medical field) is also available.
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. In this phase, we will exchange all necessary information.
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. If a State-of-the-Art document is already available, we will review and update it, if necessary.
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.
We search the literature and guideline databases for information on the medical background, similar IVDs, and medical alternatives.
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.
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).
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.
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.
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.
Would you like to acquire more knowledge? Our training is conducted by our experts and adapted to your needs, depending on the product, knowledge level of the employees, etc..
We thoroughly review your performance evaluation. Depending on your individual needs, we either work with your templates or use our tried and trusted ones.