Regulatory Strategy Support

You want to get your product to market as quickly as possible, but to do so, you need to ensure you are complying with the strict regulations mandated across the medical device industry. Failing to do so can put your business—and more importantly, your end-users—at risk. Navigating the murky waters of U.S. Food and Drug Administration (FDA) regulatory requirements, and knowing which ones your device is subject to, can be daunting, even for the most established medical device manufacturers.

Sterling can help.

Before bringing a medical device to market in the United States, it is essential to determine the proper classification and applicable regulatory requirements it must adhere to in order to ensure patient and user safety. With Sterling’s regulatory strategy support, we help you identify and address key FDA requirements for your device including:

  • Product code and regulation number determination
  • Classification determination
  • Identification of applicable standards and guidance documents
  • Confirmation or identification of potential predicate devices
  • List of applicable tests
  • Premarket pathway strategy
  • Quality system requirements 

Resources

April 15, 2021

How to Classify a Class III Medical Device

Last month, we began our series examining the classification of medical devices, with a deep dive on the differences between a class I and class II medical device. Today, we will explore the topic...
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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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