The international standard ISO 14971:2019 serves as the foundation of risk management in medical device development. At AltaSim Technologies, we’ve found that using simulation tools leads to your medical devices adhering to the ISO 14971 standard more quickly, while also maintaining and even improving your precision and accuracy.
ISO 14971
The ISO 14971 standard has been used internationally since 1998, and no medical device can be successful without complying with it. The standard outlines a systematic approach to managing risk, including identifying potential hazards (mechanical, thermal, biological, etc.), estimating the probability and severity of harm, implementing risk control measures, and monitoring residual risk and the effectiveness of controls over time. To comply with ISO 14971 and ensure design safety, there is ongoing product oversight and the use of simulation tools to maintain the commitment without slowing down processes.
Where Simulation Fits into ISO 14971
At AltaSim Technologies, we have supported many medical devices through ISO 14971 and ensured that our simulation process supports every stage of risk management. We simulate device behavior under various conditions to identify risks that are not apparent through traditional design review alone. Our engineers can quantify probabilities, mechanical fatigue, and failure, and even simulate a repeated load condition. They also specialize in collaborating on design changes and performing risk-control verification to mitigate hazards effectively. Once the models are validated, they can be modified to explore product updates, new data, or the possibility of unexpected events, keeping risk management active and adaptable.
How AltaSim Technologies Uses Modeling to Support Risk Management for Medical Devices
AltaSim Technologies can seamlessly integrate simulation into our clients’ risk management plans and ISO 14971 processes. Our engineers build models that simulate how devices perform under a myriad of conditions, including stress, misuse, and physiological variance. These models supply our clients with quantifiable data that is verifiable, reproducible, and less expensive than creating multiple physical prototypes, yet is still accepted as scientific evidence from both regulators and shareholders alike. Since the models can be modified, our customers find it easy to ensure that their entire product’s life cycle is assessed. Simulation isn’t just for design. It’s also for redesign, troubleshooting, and ongoing risk assessment.
Safety by Design, Not by Luck
Risk management is more than a regulatory hoop. It’s the foundation of responsible innovation. AltaSim Technologies can make risk management compliance with ISO 14971 easier by providing our clients with simulations and tools for identifying, mitigating, and managing risks.