Prevent Recalls & Increase Patient Safety
Advantu’s dedicated medical device team understands the unique requirements of medical devices, providing strategic support and tactical solutions for traditional, embedded software devices and networked hospital systems.
“Kris utilized the Risk Reduction Process successfully on a project which married medical devices to a hospital system for the first time – with feature changes to all aspects of the system, and it’s been running flawlessly for several years now.”
Marketing Manager – Fortune 100 Medical Device Manufacturer
Our length and breadth of experience in the FDA/ISO space allows us to perform IV&V while maintaining QMS compliance throughout the software development life cycle. We understand the necessity to follow Good Manufacturing Practices (GMPs) as part of the FDA’s Quality System Regulation (QSR: 21 CFR 820).
Advantu works with manufacturers to implement and maintain compliant quality systems. Our quality assurance professionals offer a broad range of expertise and have “hands on” experience with a wide variety of medical device products. These include Acute Care, Diagnostic, Medication Delivery & Monitoring and Patient Point of Care.
Recall Prevention In Action
We utilized our Recall Prevention Process to help a Medical Device Manufacturer on a project where they combined large quantities of infusion devices with a new hospital system for the first time. First, we showed their core team all the high risk areas in the entire system. This allowed us to reveal the critical defects lurking in the code so they could mitigate them quickly. These defects were caused by abnormal behavior so they wouldn’t have been discovered with normal testing. This system was shipped to the UK and has been operating without incident since 2015.
For Information about Recall Prevention – Kris Kelly was interviewed about our Program: https://imua-services.com/077-best-thing-can-prevent-problems-with-the-fda/
Medical Device Testing Expertise
Due to our vast experience with software quality engineering and testing – we have the capacity to ramp up quickly when clients have critical deadlines which can’t be moved. Our engineers know how to prioritize their time and can seamlessly integrate with your team in order to help you accomplish your goals – with quality, safety and product reliability at the forefront.
We supported a startup with a new medical device which needed to meet a stringent project deadline. Our lead engineer was able to quickly understand the product features and functionality – while maintaining allegiance to FDA Regulations – and create all the necessary SQE documentation in order to thoroughly test the device & integrated system. Our client was able to meet all their service level agreements on time.