FDA Medical Device Regulatory Compliance Consultants

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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

October 8, 2015

Developing Medical Device Software

"Developing Medical Device Software," New Med Device Online Article Series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, 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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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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