ISO 13485 - Risk Management and Analysis

According to the Medical Device Regulation and ISO 13485 standard, which adopts risk-based production processes as a principle, all processes that affect the safety and performance of the medical product should be planned and managed on the basis of risk analysis.

The risk file for medical devices is created on the basis of the ISO 14971 standard. . While creating the Risk Analysis File, it is necessary to have knowledge of all relevant standards, regulations and clinical data related to the medicinal product. While creating the Risk Analysis File, it is not sufficient to evaluate only the processes carried out within the company. The raw material procurement process, production, storage, transfer, sale and usage characteristics of the medicinal product should also be mastered.

Benefits of Risk Analysis

– Effective use of standards and regulations.
– Helping to identify risks.
– Effective way to minimize identified risks
– Determination of the monitoring and analysis processes of the risks of post-market products.