Who we serve:
Laboratories
Blood banks
Medical device manufacturers
Hospitals
Pharmaceutical companies
Research centers
Your questions answered
Medical device software is regulated by health authorities such as the FDA in the US, the EMA in Europe, and other national regulatory bodies. These agencies ensure that software complies with stringent standards for safety, effectiveness and security.
Our developers follow rigorous testing and software documentation procedures, including validation and verification, to ensure software performs as intended. This includes clinical trials, risk management assessments and continuous post-market surveillance to monitor real-world performance and safety.
Software as a medical device (SaMD) is standalone software intended for medical purposes (such as diagnostic or therapeutic). Software used in a medical device, on the other hand, is software embedded in or integral to a physical device, like software in a pacemaker or insulin pump.
Software updates for medical devices are carefully controlled and in many cases must go through regulatory review. Updates are typically released to fix bugs, enhance functionality or address safety issues. They must be thoroughly tested, documented and approved before deployment to ensure patient safety.
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