BIOLOGICAL EVALUATION
YOUR TASK
As a manufacturer, you must ensure the biocompatibility of your product. Biological risks, e.g. materials that cause allergic reactions, must be minimized. We can help you meet the requirements according to the ISO 10993 standard.
YOUR NEEDS
We focus on your demands.
You need a BEV for your technical documentation or for a clinical evaluation?
Are you a manufacturer of products that come into direct contact with patients?
YOUR BENEFITS
We have a large network of Biological Evaluation Experts that you can call upon and have a high level of expertise in the compilation & analysis of biocompatibility data. We create the appropriate SOPs and templates for the Biological Evaluation Plan and Report for you.
BIOLOGICAL EVALUATION AT A GLANCE
According to your needs, our biological assessment activities include the following steps.
1
Projekt 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
Categorization
The medical device in question is categorized in terms of cumulative contact duration and target tissue invasiveness.
3
Biological Evaluation Plan (BEV)
The Biological Evaluation Plan, including the planning of in vivo tests depending on the results from the chemical/physical and in vitro tests is prepared.
4
Acceptance criteria
Based on database research, the different acceptance criteria are defined (PharmEur, Toxnet).
5
Data research
It is checked whether Biocomp data of comparable products are available.
6
Data analysis
The Biocomp data are analyzed.
7
Biological Evaluation Report (BER)
The data from the Biocomp tests are summarized in a Biological Evaluation Report. If adverse data are found, there is input for adjustments in the design and manufacturing process of the product.
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.
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GAP Analysis
We thoroughly review your Biological Safety Assessment. Depending on your individual needs, we will either work with your templates or use our tried and trusted ones.
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Training
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..
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