Beijing Tigermed-Jyton Co., LTD. ——Third-party Audit

We have a complete quality management system for clinical trials of medical devices. Our audit team has an average industry experience of over 10 years. Our audit team members not only possess practical experience in the industry but also come from diverse backgrounds, including hospital institutions and national agencies. This allows us to conduct thorough evaluations of projects from a professional standpoint. The audit team is familiar with ICH-GCP and local authorities’ relevant regulations of medical device clinical study, experienced in quality management, able to comprehensively audit the clinical trial, and is actively providing high-quality audit service for clients. Our range of services includes: 1. On-site audits for medical device clinical trials and in vitro diagnostic product clinical trials study sites, as well as office audits for study documents (TMF). 2. System audits and third-party supplier audits of such as SMO (Site Management Organization) and central laboratories. 3. Preparations and support for sponsor and NMPA inspections. 4. Establishment of GCP full life cycle quality management system (QMS) for sponsors. 5. Registration of medical device clinical trial institutions.