BIOLOGICAL EVALUATION
YOUR TASK
As a manufacturer, the biological safety of your medical device has to be ensured according to ISO 10993 standard. Biological risks, such as the toxicity of materials or production residues, must be addressed and minimized.
YOUR CHALLENGES
We focus on your demands.
Do you need support in assessing the biological safety
of your medical device?
Do you need advice regarding biocompatibility testing?
Do you need to prepare a Toxicological Risk Assessment (TRA) of extracted chemical substances?
Do you need help to evaluate CMR, nanomaterials or other substances of concern?
YOUR BENEFITS
Our team has prepared a large number of biological safety evaluations according to ISO 10993 and is experienced in conducting literature searches in toxicology databases and preparing Toxicological Risk Assessments (TRA).
BIOLOGICAL EVALUATION AT A GLANCE
Not all medical devices require the same type of testing and evaluation. We tailor the scope of the biological evaluation activities to your device.
1
Project Kick-off
Together, the scope and strategic approach of the Biological Evaluation will be defined. We will establish a timeframe and deadlines, and exchange all necessary information.
2
Biological Evaluation Plan (BEP)
A Biological Evaluation Plan will be created. This includes the definition of biological endpoints according to ISO 10993-1 based on the nature and duration of body contact, collection of relevant data, and characterization of all materials, additives and productions residues.
The conclusion of the BEP will determine necessary tests to close potential gaps.
3
Chemical analysis and Toxicological Risk Assessment (TRA)
We help you to identify laboratories for performing the necessary testing (e.g., leachables/ extractables).
After the chemical analysis, a comprehensive safety evaluation of the extracted chemicals according to ISO 10993-17 will be performed.
4
Biocompatibility Testing
According to the Biological Evaluation Plan and the results from the toxicological risk assessment, biocompatibility studies are evaluated.
5
Biological Evaluation Report (BER)
The assessment of the overall biological safety will be summarized in the biological evaluation report.
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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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