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Wherever you are in your product development lifecycle,
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COVID-19 Regulatory Assistance for Medical Device EUAs

Are you struggling to achieve regulatory approval for a potentially life-saving medical device in this current COVID-19 environment? You may be able to file for an Emergency Use Authorization and receive regulatory approval through an expedited process. This will get your product to market much faster.

In our webinar, COVID-19 Regulatory Assistance for Medical Device EUAs, our Director of Regulatory Affairs, Carrie Hetrick, discuss the steps you need to take to receive an EUA during the pandemic. We discuss:

  • How to qualify for an EUA
  • The process for obtaining authorization
  • Practical tips to prepare for your EUA submission

Fill out the form to get the information you need to bring your medical device to market.

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Resources

Nick Testing Web

February 7, 2018

Hazard Analysis

What is a Hazard Analysis for a Medical Device? Medical device hazard analysis is a fundamental requirement of ISO 14971 risk management. The steps in conducting a hazard analysis entail identifying...
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5 Mistakes Medical Device Startups Make

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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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

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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