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Timeline for updating documents

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Guest user Created:   Apr 29, 2021 Last commented:   May 04, 2021

Timeline for updating documents

Our company has bought few Advisera documents regarding ISO 13485 risk management and clinical evaluation. Can I ask you a question I have been struggling to find the answer? How often should those documents be updated? Clinical evaluation plan and review; risk management plan, file, review? We are producing class I medical devices.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 04, 2021

For medical devices class I there is no strictly defined how often updates need to be done. And this is not about some time limit, but about the fact that these documents change depending on the situation. 

The most common reason for changing the Clinical Evaluation is some risk that has arisen, or if something has happened to the competition so this is the input to you as well. It is expected that clinical evaluation. The clinical evaluation for Class I medical devices generally changes every 3-5 years. 

In risk management, the situation is a little different. Every complaint you receive must be analyzed to see if it is already covered by your risk analysis. Any change of supplier, change of machine, change of production conditions, and even organizational changes must be analyzed and assessed how these situations affect the risks. This means that there will be a period that you will not change the risk analysis for a year, and then again there may be a period in which you will change the risk analysis several times within 6 months for example.

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Apr 29, 2021

May 04, 2021