Digitizing a medical device’s risk analysis to guarantee compliance

Article published on DeviceMed.

DeviceMed, GxpManager, Medical devices, Risk analysis

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.

This is a critical process. Yet it is often formalized in Excel spreadsheets, which do not comply with current security, data integrity, and traceability regulations.

An agile platform that facilitates audits

GxpManager offers its “Risk Analysis” application to meet this need. This solution includes a set of customizable, compliance-oriented functionalities that are ideally suited to risk analysis of medical devices.

It manages the entire risk management process and automatically publishes the file: identification, assessment, control, acceptability, graphic indicators, etc. The application is customized to each manufacturer’s processes and methods. It features native functionalities such as audit trail, document versioning, workflows with electronic signatures, one-click report publication, and much more…

This agile platform supports manufacturers in the digitization of their critical data. It reduces document management effort, centralizes and shares data, automates processes, enables real-time reporting, and allows controlled publication of risk management files according to manufacturers’ templates.

The message from GxpManager President Jérôme Tomaselli is clear:

“Digitizing the risk analysis process for medical devices can present a daunting challenge, but traceability, compliance, and safety benefits are considerable.”

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