Accurately Evaluate Chemical Properties to Ensure Medical Safety
- Comprehensive biocompatibility testing service.
- Bio-safety assessment plan and reporting services.
- Regulatory support team standby for compliance and market access.
- Customized chemical analysis plans.
- One-stop medical device analysis solution including other related analysis services.
- Continuous improvement based on industry feedback.
- Rigorous quality control system.
- Professional team.
- Advanced laboratory equipment.
- Timely response.
The chemical analysis of medical devices is of great significance. Its purpose is to evaluate whether harmful chemical reactions will occur or leachables will be released when the device comes into contact with living organisms, to ensure that the chemical components and materials of medical devices will not have adverse effects on patients or users. With the release of ISO 10993-1-2018, chemical characterization has become a necessary part of the safety assessment of medical devices. It emphasizes conducting risk assessment and chemical characterization first, followed by biological testing, thus highlighting the significance of comprehensive chemical analysis.
AltaNovate specializes in providing comprehensive chemical analysis services for a wide variety of medical devices. Through in-depth analysis of extractables and leachables from tested products, it precisely assesses potential toxicity and overall biocompatibility, accompanied by regulatory support services for market access. Contact us for any needs.
Our Service
Chemical analysis is a crucial way to assess the chemical safety of medical devices, mainly involving the analysis of extractables and leachables. A offers material chemical characterization and dissolution testing for medical devices, in line with ISO 10993 and other relevant standards. Additionally, biocompatibility testing services are also provided to comprehensively evaluate the product safety of medical devices.
| Testing Items |
Testing Contents |
Testing Purpose |
| Chemical Characterization of Materials |
Identify and analyze the chemical components, extractables, degradation products, etc. of the products, and combine toxicological knowledge to analyze and evaluate their risks and safety. |
Gain a comprehensive understanding of the characteristics of the finished materials of medical devices, providing a basis for evaluating the interaction with the human body during use and potential risks. |
| Chemical Analysis of Raw Materials |
Analyze and identify the raw materials used to manufacture products, determine their compositions and purities, and screen for harmful substances. |
Ensure that the quality of raw materials meets the requirements and prevents unqualified raw materials from entering the production process and affecting the basic quality and safety of products. |
| Chemical Performance Testing |
Simulate the usage conditions of medical devices in different environments, evaluate the chemical stability and chemical changes of the products, test the possible leachables and extractables released, and assess potential risks. |
Determine the substances that medical devices may release and their potential hazards, ensure the safety and effectiveness of the products during storage, transportation, and use, and ensure that no harmful effects are caused by chemical changes. |
| Chemical Residue Analysis |
Analyze and detect the chemical residues in the production and sterilization processes of products to ensure the safety of product use. |
Prevent the excessive chemical residues in the production and sterilization processes from causing irritation, allergy, or other health problems to patients, and ensure that the products meet the requirements of chemical residue limits. |
| Chemical Compatibility Testing of Packaging Materials |
Detect the chemical interactions between packaging materials and medical device products and their contents, including migration testing and adsorption testing. |
Ensure that the packaging materials do not have a negative impact on the quality and safety of medical devices, and guarantee the compatibility between the packaging materials and the products or contents. |
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Get in Touch
AltaNovate is your top choice for medical device analysis! We provide one-stop analysis services covering biocompatibility testing, sterility testing, mechanical testing, etc. Regardless of the type of your medical device and the specific testing service it requires, we are capable of offering customized testing solutions. Contact us now for free initial consultations and customized analysis.
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