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Where to find us:

250 Moonachie Rd., Suite 400, Moonachie, NJ 07074

Phone: 201-227-7569
Fax: 201-301-9169

General Info: info@sterlingmedicaldevices.com

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Resources

April 15, 2021

How to Classify a Class III Medical Device

Last month, we began our series examining the classification of medical devices, with a deep dive on the differences between a class I and class II medical device. Today, we will explore the topic...
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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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Need help with your medical device?

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FDA/CE approval with a free custom project analysis.
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Wherever you are in your product
development lifecycle, Sterling
can help.

P: 201-227-7569
F: 201-301-9169
info@sterlingmedicaldevices.com

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  • About Sterling
    • About
    • Why Sterling
    • Our Team
    • Careers
    • News
    • Events
    • Our Approach
  • Services
    • Product Development
      • Prototype Development
      • Industrial Design
      • Human Factors
      • User Experience Design
      • Software & System Development
      • Medical Device & Equipment Design Services
    • Software & System Development
      • System Development
      • Research & Human Factors
      • Electromechanical Hardware Development
      • Software and App Development
      • Cybersecurity
    • Medical Device Testing
      • Verification
      • Validation
    • FDA / CE Medical Device Regulatory Compliance Consulting Services
      • Risk Management
      • Manufacturing Compliance – GMP, QSR, ISO Review
      • Quality Systems
      • Cybersecurity
      • Tool Validation
      • Human Factors
    • Regulatory Consulting
      • Regulatory Compliance Consultants
      • Clinical Evaluation Reports
      • EU MDR & IVDR Transition and Technical Documentation Compilation
      • FDA Medical Device Regulatory Compliance Audit Program – MDSAP
      • FDA Medical Device Regulatory Compliance Consultants
      • Post-Market Development, Support, Surveillance & Remediation
      • UDI Services
    • Project Rescue
      • DHF Medical Device Remediation
    • Polarion Requirements Management, Consulting & Training
  • Our Work
    • Projects
    • Case Studies
    • News
  • Thought Leadership
    • Blog
    • Case Studies
    • Events
    • Medical Device Videos
    • Download Tools
  • Contact