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

P: 201-877-5682
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CE Premarket Approval

The EU Medical Device Directive (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 

Resources

April 8, 2021

What’s the Difference Between a Class I and Class II Medical Device?

One of the most common questions when it comes to medical device regulation is, “What is the difference between a Class I and Class II medical device?” Today, we will explore the topic in more...
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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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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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