Regulatory
ISO 14971 is the risk management standard for medical devices. This includes software as a medical device and in vitro diagnostic medical devices. It contains a structured approach for effective medical device risk management.
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ISO 14971 provides a framework to help medical device manufacturers manage risk. It is used to identify hazards, risks, ways to control those risks, and ways to effectively monitor those controls.
ISO certification adds credibility to a company worldwide. ISO itself doesn’t offer certification, but there are independent third parties that do. Even if a company doesn’t officially receive certification, they will still benefit from following the standard.
Medical device risk management is an ongoing process that requires companies to continually improve. This should be a thoroughly planned, documented and proactive process for improving a product’s design and usability during and after design and development. The different stages of risk management include the following:
A potential source of harm from using a device. This includes considering intended use and reasonably foreseeable misuse.
Consider the probability of occurrence and the potential severity.
Create a risk acceptability matrix to determine if the risks are acceptable, if they are outweighed by benefits or if risk mitigation is required.
These measures are meant for all risks, not just those deemed unacceptable. Also need to consider risks arising from the risk control measures.
After the residual risk is deemed acceptable, the manufacturer must inform users of significant residual risks.
Ensures that medical device risk management has been appropriately completed, overall residual risk is acceptable and production and post-production measures.
Collection and review of information to determine if additional risk management procedures are necessary.
Top-notch risk management standards require top-notch software solutions.
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