You may also find this article about how to develop a medical device risk management plan helpful.Ī hazard refers to a potential source of harm. You can find much of the information you need to document hazards and hazardous situations in ISO 14971:2019 Medical Devices - Application of risk management to medical devices. Hazards and Hazardous Situations: A Recapĭetermining hazards and hazardous situations is an important initial step during your risk management journey. Let’s explore the steps that should happen after you’ve determined the hazards associated with your forthcoming product. It starts at the beginning of your development project and never ceases - unless your device is taken off of the market.Įven though the risk management process is continuous, you can break it down into steps to make it more manageable for you and your team. Not to mention the risk management process itself is never-ending. It’s a lot of pressure to account for and mitigate risks so your medical device is both safe for users and meets the FDA’s exacting requirements. The risk management process for medical devices can be overwhelming.
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