Custom Medical Device Software Development | Verification, Validation, and Compliance

Use medical device software development to unlock the potential of your medical devices to improve patients’ health.

Patients and healthcare providers need technological solutions to capture, analyze, and visualize data gathered from medical devices.

At Claricode, we’re experts in medical device software development, and from glucometers to scales, Claricode has worked with many different medical devices. Medical devices constantly gather important data, but it’s often in a format that isn’t user-friendly, easy to analyze, or connected to the patient’s medical record. We integrate specific medical devices with patient and physician portals that we build to make it easier to understand and to use the data from those devices. Medical device integration software operates in real time, allowing the provider to receive and interpret live data to help with clinical decision-making or treatment plans.

Medical devices and medical device software are a critical component of patient care.

As healthcare organizations turn to more centralized and digitized systems, medical devices need software to integrate fully. Many hospitals now rely on an electronic health record and e-prescribing to communicate between providers, patients, and pharmacies. Hardware such as vital signs monitors, pulse oximeters, and blood pressure cuffs remain key to the success of a patient’s care, yet they lack the ability to connect beyond the patient’s room to their providers or a centralized hospital information system. Medical device integration software connects a medical device to an interface that makes its data readily available to patients and medical providers.

Medical device software helps monitor patients’ well-being outside of the doctor’s office.

With the right software, many medical devices are able to capture and send active data to providers. Providers can keep an eye on their patients and initiate action, all without being physically present. These connected health devices allow for better management of chronic conditions and enable providers to intercede without having to wait for the patient’s next appointment or until the patient becomes dangerously ill.

We develop unique software specific to your medical device and your organization.

Dedicated to a customer-centered experience, we collaborate extensively with you throughout the planning, development, and support phases of your project. We conduct rigorous medical device software validation, ensuring that the software conforms to the defined user needs and intended use. Our customized process allows us to not only tailor the product to your device but to your organization’s protocols and technology. We have also supported medical devices and software through the FDA 510(k) process and have a strong understanding of the medical device software verification, validation, and compliance processes.

Some of the medical devices we have developed software for include:

Activity monitors (pedometers such as Fitbits)
Blood pressure cuffs
CPAP machines
Dermascopes
Digital cameras
Glucometers
Home medical tests
Otoscopes
Pill bottles
Pulse oximeters
Range of motion detectors, including the Nintendo Wii
Specialty thermometers
Weight scales

At Claricode, we have integrated with hundreds of medical devices for both medical providers and medical device manufacturers. We offer:

Medical device software development, including rigorous medical device software validation.
Chronic disease management patient and physician portals that use medical device data to help guide care and patient behavior.
Support through the FDA 510(k) process, including the medical device software verification, validation, and compliance process.
Reliable, customized products developed by experts in collaboration with our customers.