Legal Victory Enhances Safety for Medical Equipment Customers and Patients

Ruling helps uphold FDA's crucial mandate to ensure traceability and accountability for changes made to medical devices, thereby safeguarding public safety.

MARIETTA, GA, UNITED STATES, July 17, 2024 /EINPresswire.com/ -- North American Medical (NAM), a leading medical device manufacturer, has secured a significant legal victory that ensures enhanced safety and reliability for customers and their patients. The court ruled decisively in favor of NAM’s motion supporting its bid to halt unregulated and unlicensed repairmen from tampering with its medical products.

In 2022, NAM filed a complaint against former employees for unauthorized alteration of an FDA-regulated device, intellectual property (IP) infringement, tortious interference, and breach of contract.

This ruling from the US District Court of the State of Georgia case number: number 1:23-CV-02564, helps to uphold the FDA's crucial mandate to ensure traceability and accountability for any changes made to medical devices, thereby safeguarding public safety.

Recognizing the importance of adhering to regulatory standards, the manufacturer who is accountable for upholding those standards is the best entity to assure the safety of its used devices in the field are properly maintained. “This move affirms NAM's commitment to producing and maintaining the safety and reliability of its products for patients and healthcare providers” stated Gidgette Becerra Rubin, Sr. Vice President at North American Medical. "We are pleased the court has sided with NAM as this is a crucial step for the integrity of our industry and for the well-being of our patients."

In keeping with the court order issued on May 2, 2024, the defendants are required to cease all activities related to NAM's equipment, including service, maintenance, sales of Accu-Spina devices and/or components, and consulting on or for NAM products. Additionally, NAM is entitled to liquidated damages of up to $35,000 per occurrence for future breaches.

North American Medical remains steadfast in its mission to advance healthcare through innovation and uphold the highest standards of quality and compliance. This legal victory not only reinforces NAM's leadership in the medical device industry but also highlights its commitment to protecting the interests of medical equipment customers and ensuring the safety of their patients.

For more information about North American Medical and its innovative healthcare solutions, please visit [www.namcorporation.com].
About North American Medical: North American Medical is a leading manufacturer of medical devices dedicated to revolutionizing healthcare through innovation, quality, and integrity. Focusing on patient safety and efficacy, NAM develops cutting-edge solutions that improve non-surgical treatment outcomes and enhance the quality of life for patients worldwide.

For media inquiries, please contact: [Gidgette Rubin] [rubin@namcorporation.com] [770-541-0012]

Terri Kozlowski
North American Medical Corporation
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