Beijing ZYX Medical Device Co., LTD

Regulatory Compliance Assurance: Ensure all devices meet applicable regulations (e.g., EU MDR/IVDR, FDA requirements) throughout their lifecycle. Technical Documentation Review: Verify and maintain compliance of technical files, design dossiers, and labeling. Post-Market Surveillance: Monitor device performance, manage incident reporting (e.g., adverse events), and oversee post-market clinical follow-ups. Regulatory Submissions: Prepare and submit approvals/licenses