Medical Device & Equipment Design Services

Medical product design is a crucial phase in the product development lifecycle. A mix of art and science, the design of life-improving medical devices that align with healthcare regulatory requirements and meet end-user needs is a complex process that requires innovation, precision, and advanced expertise.

Our expert designers bridge the gap between your vision and a viable product, with out-of-the-box medical equipment designs that turn loose ideas into life-changing innovations. Our medical device designs are guided by clients’ goals and the intended use of the product, the end-users’ needs, the adherence to specifications and requirements, and the mitigation of risks.

From user interface design, workflow and CAD mock-ups to the creation of 3D printed prototypes, our multifaceted medical equipment design services ensure your medical device meets clinical, commercial and technological objectives while adhering to strict regulatory requirements.

To discuss your medical equipment designs further, schedule a complimentary project analysis with our expert designers.

Resources

February 18, 2021

The New EU Medical Device Software Requirements

With the EU’s new medical device software (MDSW) requirements, the guidance related to qualification, classification, clinical evaluation and cybersecurity present challenges for software as a...
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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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people developing a product

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?

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FDA/CE approval with a free custom project analysis.
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