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.
The medical device industry continues to pioneer and improve patient outcomes all over the world. One area of growth centers on patient monitoring systems. Remote patient monitoring systems...
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.
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....
Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis. Request Free Analysis