BIOLOGICAL EVALUATION
Your task
As a manufacturer of medical devices, you are obliged to ensure the biological safety of your product in accordance with ISO standard 10993. Biological risks, such as the toxicity of materials used or production residues, must be minimized.
YOUR CHALLENGES
We focus on your needs.
Do you need support in assessing the biological safety of your medical device?
Do you need advice on biocompatibility testing?
Do you need to prepare a toxicological assessment of released chemical substances?
Do you need help with the assessment of CMRs, nanomaterials or other substances of concern?
YOUR BENEFITS
Our team has already prepared a large number of biological assessments. We carry out extensive literature searches in toxicological databases and prepare toxicological risk assessments (TRA) in accordance with ISO standard 10993.
BIOLOGICAL EVALUATION AT A GLANCE
Not all medical devices require the same type of assessment and testing. We adapt the scope of biological assessment activities to your medical device.
1
Projekt Kick-off
Together we determine the scope and strategic approach for the biological assessment and agree on a timeframe. We will agree on a timeframe, including any deadlines that must be met. In this phase, we will exchange all necessary information.
2
Biological Evaluation Plan (BEP)
First, we create a biological assessment plan. This includes the definition of biological endpoints according to ISO standard 10993-1, based on the type and duration of body contact, the collection of relevant data and the characterization of all materials, additives and production residues.
In the conclusion of the BEP, all necessary tests are determined in order to close any gaps.
3
Chemical analysis and toxicological risk assessment (TRA)
We can help you find laboratories that carry out tests for extractable and leachable substances.
After the chemical analysis, we carry out a comprehensive safety assessment of the extracted chemicals in accordance with ISO standard 10993-17.
4
Biocompatibility tests
Existing biocompatibility tests are analyzed according to the biological evaluation plan and the results of the toxicological risk assessment.
5
Biological Assessment Report (BER)
Biological safety is analyzed and summarized in the biological assessment report.