We evaluate security, usability, and functionality of medical device software, from prototypes to fully shaped products, against the industry quality requirements and standards.
When testing systems behind medical devices, we focus on such vital aspects as software sustainability and compatibility of its disparate elements, workflow stability under various loads, and cybersecurity issues.
Protect your system against operational setbacks and performance disruptions.
Compliance with industry standards
Guarantee your healthcare tech adheres to the design, quality, and security regulations for medical devices and software, including IEC 62034, HIPAA, and FDA.
Improve your product marketability with smart and smooth user experience, intuitive for both patients and medical staff.
Hedge against defects, errors, and incompatibilities in line with your device safety class.
Secure sensitive patient data from vulnerabilities and unauthorized access and assure flawless functioning of software of any class, from A to C.
Receive personalized recommendations on how to uplift your medical device software.
We will examine whether your embedded systems meet the intended operational requirements, evaluate their data processing capacity, and run regression tests to ensure the functionality is intact during bug fixing.
The Reins team will assess your medical environment to determine how stable, effective, and secure the connection between devices is and detect bottlenecks in communication and data exchange.
Thoroughly assessing the data side of your embedded system, our team will check for anti-tampering and breach protection, evaluate user authentication security, data storage and sharing, in order to track down vulnerabilities in the code, databases, and safety provisions following OWASP methodology.
With a set of tailored tests, Reins will measure stability and fault-tolerance of your medical device software, determine its load and volume capacity, and evaluate the sustainability of failover mechanisms.
We will put your medical software under scrutiny to ensure it conforms to ISO 9001, IEC 62034, and other global and region-specific standards and regulations, and pay special attention to its data protection measures.
Through a series of UX tests and user behavior simulations, our team will assess the intuitiveness of your embedded medical devices’ interfaces, the logic of their workflows, system navigation, and the user’s learning curve for getting started with the software.
We will review your medical devices against a plethora of critical requirements, detect inconsistencies and faults, and make sure it passes 510(k) or any other relevant premarket evaluation.
Using Docker, Selenium and other tools fit for the task, we will set up an automated system to ensure continuous testing of your medical device software, using stringent quality and security requirements as benchmarks.
To release medical software of high-class quality, we will ascertain no vital data gets lost on the way during data migration, and will ensure a smooth 360-degree system upgrade.
We will make sure the medical device is customized for your targeted audience’s locations and works with no glitches across 22 locales, operating consistently across multiple regions with no changes.
We get into the specifics of each software product and devise bespoke testing strategies aligned with our clients’ business context, objectives, and challenges.
Finest testing tools
With access to best-of-breed testing frameworks and tools, we can address the needs of healthcare software projects regardless of their scope.
The Reins team maintains long-standing relationships with multiple clients that last for years. Building solid partnerships has always been on our agenda.
Commitment to security and quality
We conduct testing for medical devices software strictly within healthcare regulations, and have successfully helped both manufacturers and facilities reach full compliance.