Medical device inspection is the process of selecting appropriate testing methods and tools based on relevant national laws, regulations, rules, standards, and normative documents to test and verify the safety, accuracy of data, and expected performance of medical devices. Testing is the main means of product design verification and also the main means of reducing the incidence of adverse events in medical devices
The inspection during the life cycle of medical devices includes registration inspection, factory inspection, and regular testing
Registration inspection belongs to type testing, which is a test conducted to verify whether the insulation, components, structure, and overall safety indicators of medical electrical equipment meet all the requirements of general requirements. It is commonly referred to as safety certification testing
The results of design verification are limited to indicating the compliance of the tested product's performance, and do not guarantee that the produced product can continue to meet technical requirements. This is because in addition to the finalization of the design, factors such as material use, process, and production process all affect the product's performance. The conformity of the sample does not mean that the product can continuously and stably meet the requirements, This requires manufacturers to establish effective risk management systems and processes to ensure the safety and effectiveness of products. Maintaining a risk management process or quality management system requires testing, which is a part of management activities and the data or results of testing are also the basis for conducting other management activities. Commonly seen within manufacturers are quality control process testing, factory testing, and product factory testing, which should test the necessary safety requirements and performance indicators of each equipment
For the users of medical devices, testing is also very important, as it is the main means to reduce the incidence of adverse events of medical devices. Regular testing is a planned preventive maintenance inspection, and important routine testing activities include online calibration according to the manufacturer's user manual and performance testing against the manufacturer's technical indicators before and after maintenance
Function of testing report:
1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report
2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms 3. Used as a sales report: issuing legally effective testing reports to make consumers more confident 4. Papers and research: Provide professional personalized testing needs 5. Judicial services: providing scientific, fair, and accurate testing data 6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problemsBaijian and testing process:
1. Telephone communication and confirmation of requirements
2. Recommend solutions and confirm quotations 3. Mail samples and arrange testing 4. Progress tracking and result feedback 5. Provide reports and after-sales service 6. If urgent or priority processing is requiredTesting and testing characteristics:
1. The testing industry is fully covered, meeting different testing needs
2. Fully cover the laboratory and allocate localized testing nearby3. Engineers provide one-on-one services to make testing more accurate
4. Free initial testing, with no testing fees charged
5. Self service order delivery for free on-site sampling
6. Short cycle, low cost, and attentive service 7. Possess authoritative qualifications such as CMA, CNAS, CAL, etc 8. The testing report is authoritative and effective, and is generally used in China