Medical Device Software & System Development

System Development

Sterling Medical Devices has offered industry knowledge and expertise in medical device engineering. From hardware to mobile apps, Sterling has helped bring medical devices to the market faster, all while making sure things are done correctly the first time. 

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Research & Human Factors

Sterling Medical Devices has decades of experience using human factors engineering in order to improve the design of medical devices. By using Human Factors Engineering to influence the design, Sterling can ensure the best compatibility between the user and the device.

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Other Services

Electromechanical Hardware Development

Hardware engineering is often required for many of the medical devices we develop for our clients. Since both are crucial to the development of a device, we have created systems to help clients during their device’s development process.

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Software and App Development

Medical device software development is an ever-evolving field within the medical device industry, and it is growing increasingly complex in design and functionality. This constant growth matches the growing need for enhanced patient care and therapies. 

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Cybersecurity

At Sterling, our team uses agile project management methods to eliminate extraneous elements that could threaten the medical device’s cybersecurity, create vulnerabilities, or present other potential risks associated with each individual medical device—all while moving the devices forward in the approval process.

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Resources

October 24, 2018

Software FMEA

The Effective Software FMEA Risk Management Approach Software FMEA, (Software Failure Modes and Effects Analysis) is a method of risk management that identifies single-fault failure modes in...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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