Global
- Assist companies with enterprise registration;
- Help enterprises submit FDA premarket notification 510(k);
- Guide companies to establish quality management systems and conduct third-party simulated factory audits.
- Provide ISO13485:2016 system consulting and training;
- Review CE technical documentation and all performance test reports;
- Complete clinical evaluation reports in compliance with EU regulations.
China
- Patent application & evaluation
- Product performance & clinical value demonstration
- Expert review meeting video arrangement
- Registration preparation: Classification, pathway planning, technical document pre-review
- Registration testing: Sample delivery, issue coordination, report follow-up
- Biological evaluation: Test arrangement, progress follow-up & report compilation
- Animal study: Protocol review, test supervision & report management
- Clinical affairs: Clinical evaluation and trial quality control
- Regulatory review: Document submission, progress tracking & problem coordination
- QMS on-site audit: QMS consulting and external audit service
- Agency & translation: Professional agency and document translation for overseas clients