Agile Medical Software Development

Agile Medical Software Development

Agile is a type of risk management that mitigates risk by testing after each small change in your medical device.  Medical device software development is an ever-evolving field within the medical device industry, and it is growing increasingly complex in design and functionality.  The increase in complexity makes it extremely important to test your device after every small change to your software, in order to mitigate risk.

  • Design History File (DHF) Remediation
  • Get products to market quickly and cost efficiently
  • Utilize state-of-the-art tools and electronic test equipment
  • Proven track record of FDA/CE approvals
  • Software verification and validation testing

Sterling Medical Devices is ISO 13485 certified and we work with medical device companies throughout the entire software development lifecycle using state-of-the-art tools and equipment. Our team will help you to align your medical device software development efforts with FDA expectations and gain faster regulatory approvals. We can help you move toward your best practices, such as leveraging safety assurance case principles to clearly demonstrate the safety of your medical device product.

 
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About Sterling Medical Devices

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

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    Dan Sterling Photo of Dan Sterling President
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 dan@sterlingmedicaldevices.com
    John Campbell Photo of John Campbell VP of Operations
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jc@sterlingplm.com
    John Fargo Photo of DanJohn Fargo PLM Manager
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jf@sterlingplm.com