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

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CE Premarket Approval

The EU Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) that has been the standard for medical device regulation in the EU since 1993. If you need help to update your documentation from MDD to MDR/IVDR compliance, Sterling can help. Under the MDR, your CER and PMCF are live documents that must be routinely updated. Sterling can help update these documents as well.

Sterling can help.

Before bringing a medical device to market in the EU and other parts of the world that follow CE Mark regulation, it is essential to determine applicable regulatory requirements it must adhere to ensure patient and user safety. Sterling’s regulatory team offers services to help you identify and address key CE Mark requirements for your device including:

  • CE Mark documentation support, specifically:
    • EU MDR to IVDR submission documentation gap analysis
    • Transitioning from MDD to MDR for compliance
    • EU MDR/IVDR documentation remediation
  • Notified body communication support services
  • Notified body audit support and remediation
  • MDR clinical evaluation report support services:
  • IVDR Performance Evaluation Report (PER) support services:
    • EU IVDR PER gap analysis
    • EU IVDR PER development and transition support
    • EU IVDR PER remediation
  • PMCF (post market clinical follow-up) plan development
  • PMCF updates
  • Risk Management File development and updates
  • Human Factors testing support


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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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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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