Third-party testing center for medical device products
The third-party testing center for medical device products "CCIC Huatongwei"
Founded in 1999, with 21 years of medical product testing experience, it is a nationally recognized third-party medical testing laboratory
The company needs to refer to relevant laws and regulations when compiling product registration information. Among them, research data is an important part of the product registration data submitted by the company, which usually includes five main parts: product performance research, biocompatibility research, sterilization process research, product effectiveness and packaging research, and preclinical animal experiments. content. Each research material is closely related to product inspection, and third-party testing services can be combined with the company's verification requirements to prepare these research materials.
Third-party testing center for medical device products
The first is product performance research: this part mainly depends on product technical requirements. For test items, you can first visit the national bureau website to find the relevant technical guidelines, product national and industry and international standards, or formulate your own technical requirements based on similar standards.
Hotline: 400-963-0755 orMail box： roy.yi@szhtw.com.cn
China Medical Device Testing Corporation《huatongwei》
Biocompatibility research: The current GB/T 16886.1-2011 standard will focus on how to conduct biological experiments to determine whether it is necessary to conduct biological experiments through existing information analysis methods, and to select raw materials for consideration in the product development stage. then. The biological evaluation of medical devices should focus on prioritizing the analysis of chemical components and the use of in vitro models to minimize the number and exposure of experimental animals.
For example, for polymer products, the chemical formula of each component material must be considered and evaluated, including adhesives, known and suspected impurities, and all components related to processing. Packaging materials may transfer chemical substances. The impact on the product on medical equipment. Attention should also be paid to the correlation between the manufacturing materials, finished products, leachables or degradation products of the product and the overall toxicological assessment of the equipment.
Generally, in the biological assessment process, attention should be paid to using all relevant information (including materials, literature, in vitro and in vivo experimental data, and clinical experience) to integrate all useful information for safety assessment.
After the entire evaluation is completed, if biological experiments are required, a qualified laboratory needs to be found to complete this part of the work.
Sterilization process research: For polymer products, most of them are provided aseptically, so sterilization verification is required. Verification is not only the sterility test of the final product, but also the confirmation of the sterilization process. Therefore, it is necessary to confirm that all links of the sterilization process meet the technical standards and select the correct sterilization working parameters.
Product effectiveness and packaging research: The shelf life stability report of the product can be carried out simultaneously with real-time testing and accelerated aging. Polymer materials generally undergo accelerated aging at high temperatures. Before obtaining real-time expiration date results, it is necessary to perform accelerated aging experiments to provide experimental data to determine expiration dates.
Pre-clinical animal experiments: The safety and effectiveness of medical devices should be evaluated using scientific and reasonable evaluation methods. Animal experiment is one of the important methods. The main purpose is to initially assess the safety, effectiveness and feasibility of medical equipment. The necessary animal experiments have the following important meanings:
1) Provide corresponding evidence support for product design finalization;
2) Provide a basis for whether the medical device can enter the clinical research stage, and realize the protection of the clinical subject;
3) Provide reference for whether medical devices can be exempted from clinical trials or how to design clinical trials.