The growth in the medical device usage has led to increase a complexity of making the medical device safe for human use. Risk management process need to establish by the medical device manufacturer to ensure device safety, usability & regulatory compliance.Medical device manufacturer shall establish, implement, document and maintain an ongoing risk management process throughout the life of a medical device.
Risk management is a systematic approach of identifying the hazards, evaluating the risks, controlling the risk and monitoring all kinds of risks at all stages of the product realization starting from Raw material to post production activity as per the standard ISO 14971:2019. As such, ISO 14971 is acknowledged by FDA inside the21 CFR part 820用于医疗设备的QSR。所有风险管理活动和记录都在风险管理文件中捕获。
风险管理过程包括以下要素：
- Risk Management Plan
- Risk Analysis
- 风险评估
- Risk Control
- Evaluation of overall residual risk acceptability
- 风险管理审查
- Production and post production information
Risk Management File provide a traceability between each identified hazard to the risk analysis, the risk evaluation, Implementation & verification of risk control measures, the results of the evaluation of residual risks.
Medical device manufacturer need to prepare following documents which covers the entire Risk Management requirements as perISO 14971：2019。
- Risk Management Plan
- 初步危害分析
- Design Failure Mode Effect Analysis
- Process Failure Mode Effect Analysis
- Application Failure Mode Effect Analysis
- 风险收益分析
- Risk Management File & Report
结构风险管理文件的最佳方法：
- 首先，了解风险管理术语，例如潜在的故障模式，危险情况，危险，潜在伤害，问题的来源，风险控制措施等。
- Consider the inputs from all the departments while carrying out the risk management practice like Sales & marketing, Design, QA, Production, purchase, stores, Regulatory & clinical etc.
- 记录预期的用途，可预见的滥用，确定与安全性有关的角色，识别危害和有害情况，这些情况可能会影响产品，用户和患者的安全性。
- Decide the criteria for Risk acceptability based on the severity of the Harm and probability of the occurrence of the risk.
- Gather the information or data for estimating the risks from sources of published standards, field data from similar medical devices which are already in use including publicly available reports of adverse events, usability tests employing users, clinical evidence, scientific or technical investigations, expert opinions etc.
- The team can use one or more risk control options in the priority order
- 固有的安全设计和制造
- Protective measures in the manufacturing process or in the medical device itself.
- Information for safety.
7.The team should collect and review the information relevant to the device in the production &post production phases.
8.Consider Risk Management File as a live document and it should be accessible to the employees, stakeholders, outsourced vendors so that they can also update the Risk Management File and ensure that risks are mitigated to an acceptable range.
Assuming you have risk management file, then making it up-to-date can be very challenging as it will depend on Quality system you use. Our team keenly observe the facts and analyze the data, as医疗设备顾问we guide our clients to choose correct QMS system, apply ISO standard accordingly and create accurate and up to date files.
