Services

Wherever you are in the Medical Device Development Process,
Sterling Medical Devices will add immediate value to your engineering efforts.

Product Development

We can turn any medical device idea or concept into a reality

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Software & System Development

We can build the components that make your device
operational

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Medical Device Testing

We can test to assure quality performance and operation

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Regulatory Affairs

We can help your device achieve and maintain regulatory compliance

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Quality Assurance

We can optimize your quality management system

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Project Rescue

We can address your concerns with a current project

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Polarion Requirements Management

We can customize your Polarion instance to improve efficiency

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Supply Chain Interruptions

We can monitor material shortages and prevent production delays

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Resources

selection agile development

November 12, 2021

Agile Development in a Medical Device Company Can Save Time and Money

“The Sterling Approach” to medical device design focuses on our customers’ experience -  a critical component is our Agile project management. Agile development in a medical device company is...
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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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November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
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