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Testing of biocompatibility of biomaterials and medical devices (09 DE 0855 3DNF)
A German SME working in the area of biocompatibility testing for biomaterials and medical devices according ISO 10993 is interested in technical cooperation and commercial agreements with technical assistance to support industrial and research partners in biocompatibility testing and CE mark certification.
Country: Germany
Type: OFFER
Date: 29.11.2011
Biomaterials and medical devices need biocompatibility testing before entering clinical studies and to get the CE mark. These tests should be assessed on a case-by-case basis. Testing strategies are depending of the device category and composition.
A German SME has the expertise and experience to set up strategies and to test biomaterials and medical devices according to ISO 10993 on cytotoxicity, haemocompatibility, local effects after implantation, irritation, sensitization, genotoxicity, acute and chronic toxicity and chemical characterization.
The company offers comprehensive know-how, expertise and services that meet all requirements for the CE approval tests and development support. They offer to prepare a customized test strategy for each medical devices or biomaterial depending on the requirements of the product to be tested.
The classification of products and the selection of appropriate test methods are carried out on the basis of component analysis, where the specific characteristics of the product or material are tested in order to deliver a clear and reliable overall result.
A test procedure investigates the effect of a product from various perspectives. In the process, so-called quantitative and qualitative procedures are used, precisely evaluated and extensively analyzed.
The company has ISO 17025 accredited laboratories. They are in a position to provide the required safety verification for medical devices. Their evaluated variety biological test procedures conform to the national and international guidelines according to ISO 10993.
Innovative Aspects:
The German SME
- has many years of experience in the field of contracted services for risk analysis,
- is an accredited laboratory,
- can offer customized test strategies for CE mark certification and post-marked monitoring of production process,
- delivers reliable results.
They have highly-qualified test strategies and the technical knowledge to help the partner in each step of the way to the optimized medical device and product.
Degree of development:
Patents/Rights: Secret know-how
Requested Cooperation: Quality control, Testing of new applications, Adaptation to specific needs
The German company is generally interested in technical co-operation concerning the testing of the biocompatibility of biomaterials and of medical devices. The industrial partner would assign the testing and deliver the specifications and products/materials for the biocompatibility testing. The German company is interested in designing solutions for new products in co-operation with the partner.
In which concrete area is depending on the interest of potential partners, e.g. the medical devices industry, research institutes and others. The company is also interested to support these partners in the control of the quality of their products in direction of biocompatibility.
Type of Organisation:
Status: NEW
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