Creating a Risk Assessment Document (according DIN EN ISO 14971:2018/MEDDEV 2.7.1) for a simple Medical Device

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)!