FDA Medical Device Regulatory Compliance Consultants

Two men looking and typing on a computer

You want to get your product to market as quickly as possible, but to do so, you need to ensure you’re 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 regulatory requirements, and knowing which ones your device is subject to, can be daunting, even for the most established medical device manufacturers. 

At Sterling Medical Devices, we have FDA medical device regulatory compliance consultants that help you achieve regulatory, quality, and clinical compliance with country-specific requirements. With intelligence on the most up-to-date requirements, our FDA regulatory consultants will lead all clinical and regulatory program management activities, so you don’t have to.

More specifically, we will:  

  • Create and implement clinical and regulatory plans, synopses, and protocols.
  • Conduct pre-submission meetings.
  • Author regulatory packages that ensure compliance while aligning to company objectives.
  • Submit filings to the FDA regulatory compliance authorities.

With vast expertise interpreting local requirements across the globe, our FDA regulatory consultants offer worldwide regulatory strategy and compliance support that includes: 

  • U.S. Premarket authorization (510k) applications, 513g classifications, premarket approvals (PMA), De Novo petitions, emergency use authorizations, investigational device exemptions (IDE), and UDI services. We’ll also interact with local agent services and investigational review boards on your behalf. 
  • EU technical file preparation and submissions, CE marking and approvals, CER writing, and updating, EU MDR consulting, gap analyses, post-market clinical follow-up (PMCF) plans and reports, periodic safety update reports (PSUR), and post-market safety reports (PMSR).
  • Country-specific submissions in emerging countries.
  • Clinical protocol and study development.

Resources

Hands compare spinal x-rays

January 15, 2021

Three Takeaways from the Human Factors Engineering & Usability Studies Congress

In early December, I had the good fortune of attending the Human Factors Engineering & Usability Studies Congress online. Although the event could not be held in person, for obvious reasons, it...
Read More >
Sterling Medical Devices's Dan Sterling speaking

December 17, 2020

Here in New Jersey, Sterling Medical Devices Makes Med Tech to Order

Dan Sterling of Sterling Medical Devices | Screenshot by Esther Surden Suppose you are developing an implant that involves both hardware and software, or an external device for diagnosing a...
Read More >
healight

November 5, 2020

Healight: The Moonshot Not Yet Heard Round the World

Imagine a technology so innovative and groundbreaking in its potential impact that its sponsor is calling it “a moonshot” and “an opportunity so big you could build an entire company around...
Read More >

Need help with your medical device?

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