Free Analysis Offer

Let Sterling Medical Devices show you how to move your idea from concept to prototype to FDA/CE approval with a free customized analysis.

You’ll meet with our medical device analysis team and we’ll listen to your needs and understand your situation. Then, we’ll create a product development strategy proposal that includes required deliverables, an investment schedule, a regulatory plan, and a working timeline – everything you need to support a successful FDA/CE submission. And we’ll do it at no cost. We’re confident that we can show you why it pays to start with Sterling Medical Devices.

Your free customized analysis will include details on:

  • Full life cycle development and testing
  • Project management
  • Requirements capture
  • Architectural design
  • Risk planning and hazard identification
  • Software design and implementation
  • Software/Hardware Verification

You bring your vision, we’ll take care of the rest.

If you’d rather speak right away, call us at
201-227-7569

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Resources

CAPA issue resolution assistance

October 7, 2018

ISO 14971

Considered the internationally accepted standard for the medical device industry, ISO 14971 is a guide for risk management of medical device manufacturing....
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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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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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