At the beginning of 2022, the results of the project were received - Taikang Medical Doppler Fetal Aspirator obtained FDA 510K certification approval with K number 211940.
The client is a start-up medical device enterprise located in Pingshan. This project is an FDA 510K certification application submitted to the United States. The client attaches great importance to it, and after a round of comparison in the consulting circle in Shenzhen, they finally chose Rui Enni Consulting based on the recommendation of the testing laboratory and the promotion of high cost-effectiveness. At the beginning of the project, our consultant planned suitable inspection items for the client and assisted them in reviewing and providing relevant documents before the report was issued.
Throughout the entire audit process, a round of supplements was made. In addition to the routine descriptive issues in the explanations, the auditors also made some audit findings and recommendations on the security report, performance report, and EMC report. At the same time, auditors pay special attention to the safety of batteries. In addition to testing reports, they also require a quality control plan for the battery production process. These issues are quite common for us, and we promptly analyzed and completed the rectification after receiving the audit findings.
The FDA510K certification for the project was originally expected to be approved by the end of December 2021, but was postponed to early January 2022 due to the Double Dan Festival in the United States. Okay, let's start the new year with a beautiful outcome.
