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Preparedness and Your Regulatory Strategy Whitepaper

Preparedness and Your Regulatory Strategy Whitepaper

Does your regulatory strategy come into play only at the end of your development process? If so, that’s a big mistake—one that can have disastrous consequences for your product. Building a marketable medical device in the U.S. requires a vast amount of regulatory preparedness from the first day of development. But knowing what to include or how to build your regulatory strategy can be daunting, even for the most established medical device manufacturers.

In this white paper, we outline the most important elements to include in your regulatory strategy— whether you are seeking FDA certification, clearance, or approval—to help ensure you meet the requirements that correspond to your device’s classification.

They include:

  • Product code and regulation number determination
  • Classification determination
  • Identification of applicable standards and guidance documents
  • Confirmation or identification of potential predicate devices
  • Applicable tests
  • Regulatory pathways
  • Quality system requirements

Download Preparedness and Your Regulatory Strategy today to ensure your device is well positioned to meet all your regulatory obligations. 

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Resources

Doctor examining medical device report

December 20, 2021

A Guide to FDA Design Controls for your Medical Device

Medical devices hold great responsibility and risk – if they aren’t working properly, there could be dire consequences for a person’s health and potentially life. Because of this, they are...
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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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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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