Creating a Clinical Evaluation Document (according DIN EN ISO 14971:2018/MEDDEV 2.7.1) for a simple Medical Device (personal lubricant)
- risk analysis
- risk assessment
- risk control
- Evaluation of the acceptance of the overall residual risk
- risk management report
- list of applied standards
For personal lubricants in general and following variants:
1. water-based lubricants
2. silicone oil-based lubricants
3. water-silicone-oil mixture-based lubricants
4. vegetable oil-based lubricants
Minimum 50 pages.
A proof of medical qualification is required (prior to placing the order)!