Expertise.
Biocompability Studies.
Ensure the safety and compatibility of your medical devices in accordance with ISO 10993.
Secure?
Do your products meet the strict requirements of ISO 10993 and do you ensure patient safety?
Efficient?
Are your inspection processes optimized to save time and resources while still meeting all regulatory requirements?
In the long term?
Are your biocompatibility tests designed for sustainable and safe product development?
Ensure the biological compatibility of your medical devices.
Biocompatibility Studies - Comprehensive testing of biological compatibility.
Our biocompatibility studies ensure that your medical devices are safe and suitable for human use.
The biological compatibility of your products is crucial in order to avoid undesirable reactions. We support you in carrying out the necessary tests and documentation for regulatory submissions.
Our services include:
- Cytotoxicity tests: Evaluation of cellular compatibility to ensure that your products do not have toxic effects on cells.
- Sensitization and irritation tests: Check for potential allergic reactions or skin irritation to ensure safety of use.
- Systemic toxicity: Tests to assess the systemic effects of medical devices to ensure their safety in long-term use.
- Long-term toxicity and carcinogenicity: Studies on long-term tolerance and the potential risk of carcinogenicity with long-term use of medical devices.
- Regulatory consulting: Support in meeting all regulatory requirements in accordance with ISO 10993 and international standards.
Biocompatibility Services at a glance.
Our biocompatibility studies offer you comprehensive support in the biological testing of your medical devices to ensure the highest safety standards.
Cytotoxicity tests.
- Checking the cellular compatibility of your medical devices
- Detailed reporting for regulatory submissions
- Implementation of measures to minimize risks
Sensitization and irritation tests.
- Carrying out skin irritation and sensitization tests
- Identification of potential allergic reactions
- Detailed protocols for compliance with ISO 10993
Systemic toxicity.
- Determining the systemic effects of your medical devices
- Carrying out toxicity tests on suitable models
- Ensuring safety for patients
Successful biocompatibility studies for safe medical devices.
Our biocompatibility studies support companies in complying with the highest regulatory requirements
Conducting biocompatibility studies for a medical technology company
Biosafety validation for a pharmaceutical company
Biosafety validation for a pharmaceutical company
Challenge.
A medical technology company had to ensure that its products met the requirements of ISO 10993.
Measures.
- Performance of cytotoxicity tests and sensitization tests according to ISO 10993
- Advice on the selection of suitable test methods and study designs
- Preparation of detailed reports for submission to the supervisory authorities
Results.
- Proof of the biological compatibility of the products
- Successful approval of products on the European and American markets
- Long-term optimization of product development with regard to biocompatibility
Success.
The company was able to successfully obtain approval for its products and sustainably improve its development processes in the area of biocompatibility.
Ensure the biological compatibility of your products with our Biocompatibility Studies.
Our Biocompability Studies portfolio.
Our Biocompatibility Studies Service portfolio offers comprehensive solutions for biological testing and evaluation of your medical devices to ensure the highest safety standards.
Our cytotoxicity tests evaluate the cellular compatibility of your medical devices to ensure they are safe for human use. We provide detailed reports for submission to regulatory authorities and support you in identifying and minimizing potential risks at an early stage.
Our sensitization and irritation tests check the potential of your products to cause allergic reactions or skin irritation. We work closely with you to ensure that your products meet the requirements of ISO 10993 and provide comprehensive documentation for regulatory submission.
Systemic toxicity tests help to evaluate the systemic effects of your medical devices. Our experts carry out careful tests to ensure that your products have no toxic effects on the organism and that patient safety is guaranteed.
We implement automation solutions to make the verification and validation process more efficient and ensure quality. Automated workflows improve traceability and reduce manual errors.
For products that remain in the body long-term, we offer long-term toxicity and carcinogenicity testing. These tests are crucial to ensure the long-term safety and tolerability of your medical devices and to meet regulatory requirements.
Our regulatory consulting supports you in meeting the requirements of ISO 10993 and other international standards. We guide you through the entire process, from planning and conducting the tests to preparing the necessary documents for regulatory submissions.
Our Life Science Solutions
Three consulting approaches for regulated industries.
Compact explanation, clearly defined.
The combination of strategic consulting and operational implementation – flexible, agile, and perfect for dynamic projects.
Structured management of complex projects with a focus on deadlines, quality, and reliable control.
Well-founded market and competition analyses as well as clear strategies for sustainable positioning and growth.
Ensure the biological compatibility of your products.
Related topics for the biosafety of your products.
These supplementary services support you in evaluating and ensuring the biocompatibility of your medical devices: