Partner with a highly-experienced, focused, and flexible group of experts who will help see your mobile medical device project through to completion the right way.
Experience with 510K, PMA and CE Class I, II and III devices
Get products to market quickly and cost efficiently
Utilize state-of-the-art tools and electronic test equipment
Proven track record of FDA/CE approvals
iOS, Android, and Linux Application Development
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Mobile Technology is Revolutionizing Medical Devices
Smartphones and tablets are quickly becoming essential healthcare tool in our new era of digital health. Bringing any medical device to market is a complex process, and mobile medicine (mHealth) only adds further complexity, with challenges that need to be understood to assist in the design and development process. Choosing to work with Sterling Medical Devices could make all the difference.
Established in 2015, the Breakthrough Devices Program replaced the Expedited Access Pathway and Priority Review for medical devices. The designation of a product as a breakthrough medical device...
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