Service

Professional Training

Provide registration-related skill training for personnel, special training on sustainable compliance for enterprises, and customized services.
   

1. Regulatory training

This training is provided periodically at different regions.

1. Description on medical device regulations

2. Classification

3. Innovative medical devices/prioritized review and approval

4. Registration testing

5. Clinical trial

6. Registration material submission

2. Quality management system training

This training can be provided at a place and time appointed by the enterprise.

1. Training on quality system construction

2. Training on system operation & maintenance

3. Training on audit response

3. Clinical training

This training is provided periodically at different regions.

1. Interpretation of medical device clinical trial-related regulations, practice of Good Clinical Practice (GCP) and case analysis;

    2. Management for medical device clinical trials of the research center;

    3. Audit requirements and common problem analysis of medical device clinical trials;

    4. Key points in preparing clinical assessment reports and clinical trial-exempted reports, and case analysis;

    5. Common problem analysis of clinical trial registration and review for medical devices;

    6. Key points of clinical trial protocol design and case analysis;

    7. Common problem analysis of clinical trial registration and review for IVD reagents;

    8. Quality management and precautions of clinical trials for IVD reagents.