Guest user Created: Feb 13, 2020 Last commented: Feb 14, 2020

Risk Analysis

I am working for a medical device distributor and retailer company which is one of the biggest retailers in XYZ. We have decided to have a QMS and ISO 13485 certificate. Firstly, we tried the understand department processes after that we want to know control points in our system. Then we will work for procedures, instructions, lists, and forms. I want to implement an effective risk management system for the current situation. I need to know that what is your suggested way for following issues. creating a team for QMS and also risk management, defining risk management plan, risk assessment methodology, risk analysis, implementation of risk control measures, risk and benefit analysis detection of failures, reports. I have your premium preview about risk management and hazard procedures and related documents. If I buy the Premium document, can I find the way of doing the business? I know ways are depending the organization. However, the methodology and doing business about risk assessment for medical device retailers can be the same. I trust your experiences. What is your advice about the situation? Thank you very much, best regards.

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Kristina Zvonar Brkić Feb 14, 2020

First you need to define the risk management team. The next step is to define the risk management plan and select the methodology for risk assessment. Most use methodology is FMEA (Failure mode and effects analysis), but of course, you are free to use any methodology that you find applicable, and that covers all aspects of SO 14971:2019 Medical devices — Application of risk management to medical devices. After you define your methodology, you execute risk management. According to the ISO 14971:2019 following steps must be covered: risk identification, risk estimation, risk evaluation, implementation of risk control measures and estimation of residual risks.

For more details, please see the following article:

How to use ISO 14971 to manage risks for medical devices https://advisera.com/13485academy/blog/2017/09/21/how-to-use-iso-14971-to-manage-risks-for-medical-devices/

Our Premium toolkit has step-by-step guidance on how to perform risk management processes, how to perform identification, evaluation, and addressing of risks that arise from design and development, production and service delivery, sterilization, and post-delivery processes. Also, in our Toolkit is described which persons need to be involved according to their role in the organization. Recommended technology is FMEA (Failure mode and effects analysis). All reports required by new ISO 14971:2019 Medical devices — Application of risk management to medical devices are prepared so that you can totally be in compliance with the state-of-the-art. When you buy the Toolkit and start to implement documents, you have a one-hour free talk with the consultant, so for any other doubts, you are free to request a call with an expert.

You can see the details of the ISO 13485 & ISO 14971 Premium Documentation Toolkit here: https://advisera.com/13485academy/iso-13485-iso-14971-premium-documentation-toolkit/ "

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Feb 13, 2020

Feb 14, 2020

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Risk Analysis

Risk Analysis

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