Digitizing a medical device’s risk analysis to guarantee compliance

A medical device’s risk analysis is an essential step in ensuring that it complies with current regulations and is safe for users. In this field, digitizing critical data helps ensure data compliance, safety, and reliability.

Medical devices are subject to strict regulations (EU 2017/745, ISO14971, 21CFR part 11…) to guarantee their effectiveness and patient safety. In turn, these texts require compliance with demanding standards for medical device design, manufacture, packaging, labeling, and use. The risk analysis process involves studying past risks and identifying and assessing potential threats to determine the measures to minimize these risks.

There are ways in which these can be assessed, including using risk management solutions that identify weak points and draw up mitigation plans to alleviate them. The aim is to ensure that the risks associated with the use of medical devices, whatever their class, are reduced to an acceptable level, and that the benefits of the device outweigh the risks. The risk management process comprises several stages:

• Risk identification,
• Assessing them in terms of probability of occurrence and severity,
• Controlling unaccepted risks by implementing corrective actions,
• Assessment of residual and/or collateral risks.