The marketing and development of medical devices involves risks and previously unidentified problems, regardless of the stage of the product life cycle. Designing, ensuring and certifying that there are devices that are safe for human interaction, whether in daily patient care, invasive or non-invasive procedures, diagnostics or research, requires in-depth assessment and anticipation of failures, which Risk Management makes possible.
Capturing and assessing all risks is both difficult, time-consuming and error-prone, as many medical device manufacturers today depend on traditional, paper-based risk management processes.
Failure to properly identify and Mitigate risks can result in product failures related to inadequate documentation, or product malfunctions resulting from insufficient testing or simulation.
There are many benefits of Risk Management.
The Risk Management process aims to reduce risk to the lowest possible level to prevent harm to the patient, operators or other stakeholders. Ensuring safety is the main reason why risk management is applied to medical devices. It is also a legal requirement and in order to obtain FDA or European MDR approval to market a product, you must have a documented Risk Management process in place.
Increase your risk management effectiveness. Learn more about how to improve your risk management processes with automation and change control.
Download the whitepaper: Risk Management in Medical Device Development with ARAS PLM