About MEDDEV 2.7.1 Rev 4, compared with the third edition, the fourth edition gives more guidance, manufacturers should be from the comprehensive consideration of the issue to strive for clinical evaluation document integrity and scientific.
Frequency of clinical report updates
2. Qualifications of report writers and evaluators
3. Assessment reports need to have clear measurable objectives
4. Determination of the level of technological advancement
5. Scientific validity and effectiveness of the data
6. Comparison of the device
7. Data acquisition of the comparative device
8. p>
8. when clinical trials are needed
9. post-sale surveillance and post-sale clinical follow-up
10. risk-benefit.
11. Other
About MEDDEV2.7.1 Rev 4, SUNGO can assist you in:
1. Assisting in setting up a clinical evaluation program;
2. Setting up a clinical evaluation protocol;
3. Searching for equivalents and performing equivalence analyses;
4. Searching literature and other clinical data;
5, Clinical data analysis;
6, Completion of the clinical evaluation report;
7, Full English clinical evaluation report;
8, Certification body review and approval.