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.
Bridging the Gap between Good to Even Greater All medical devices and software are required to undergo a series of mandatory safety testing in order to satisfy standards such as the FDA Quality...
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.
Controller to Power Groundbreaking New Multi-Pump Mechanical Circulatory Support Device Medical Device Need A controller for an implantable heart pump that...
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