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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

difference between project management systems

May 3, 2021

What’s the Difference Between ALM and PLM?

The terms Application Lifecycle Management (ALM) and Product Lifecycle Management (PLM) are frequently used interchangeably. And while the two are often intertwined, they are not the same thing....
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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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