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Interested in learning more about how we can work together in your current or next medical device design project?

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Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169

Regulatory Affairs

At Sterling, we know all there is to know about the comprehensive requirements mandated by dozens of regulatory bodies worldwide.

Our Regulatory Affairs services include:

FDA Premarket Approval

We’ll help you comply with the strict regulations mandated across the medical device industry, so you can get your product to market faster. Whether you need help with regulatory strategy, device classification, FDA human factors documentation, or premarket clearance and approval, we’ve got you covered.

FDA Post-Market Surveillance

Our regulatory experts will help you meet post-market surveillance (PMS) requirements to ensure the continued safety and effectiveness of your device in the real-world setting.

We also offer advanced expertise in the following areas:

  • CE Premarket Approval
    We’ll help you identify and address key CE Mark requirements, so you can get your device to market faster with less confusion.
  • CE Post-Market Surveillance
    With a complex understanding of the legal and regulatory requirements for marketing products in the EU, our team will guide you through the CE post-market surveillance process to ensure your device is safe and effective in the real-world setting.
  • International Regulatory Requirements
    Sterling’s team of regulatory strategy experts will help you identify and address key international requirements for your device.
  • Medical Device Risk Management
    Whether you need to design a new product or improve an existing one, your medical device risk management process must be rigorous, especially if you are trying to gain FDA and CE approval. Leave it to us.
  • FDA US Registered Agent
    If you manufacture, prepare, propagate, compound, or process a drug or device outside the U.S. that’s imported into the U.S., we can act as your official US agent, serving as a liaison between your organization and the FDA.
  • Medical Device Clinical Research and Consulting
    Without the right resources to manage the complex process for the regulatory review and approval of your medical device, you run the risk of delays and rising costs. We’ll do it for you.
  • Usability Studies
    With advanced expertise in medical device usability testing, we’ll help ensure the device you build works as intended for the consumer while meeting the ISO 62366-2015 and IEC 60601-2022 standards and FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices.


October 9, 2014

5 Mistakes Medical Device Startup Companies Need to Avoid

The path through the FDA approval process to market may seem perilous, but avoid these five common mistakes, follow advice from Sterling’s Bruce Swope and Erik Hilliard, and your medical device...
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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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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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