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Jeni Leberknight

Jeni Leberknight

Regulatory Sales

Regulatory Sales Associate Jennifer Leberknight brings extensive quality management and regulatory knowledge to the team at Sterling Medical Devices. Ms. Leberknight works with prospective and current clients to understand their business goals, share the breadth of service opportunities Sterling offers, and ensures their regulatory needs are met. She has comprehensive experience in process engineering, project management, pharmaceutical and medical device manufacturing, Quality Management Systems (QMS) compliance, safety and hazard analysis, product design and development, and Corrective Action and Preventive Action (CAPA) and nonconformance investigations. Ms. Leberknight is a certified internal auditor and earned her Bachelor of Science from the University of Wyoming. She also holds a doctorate in Chemical and Biological Engineering from South Dakota School of Mines and Technology. She appreciates the opportunity to collaborate with different partners on a diverse array of products and supporting their path to market.

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Resources

technician manufacturing medical devices

July 21, 2021

Good Manufacturing Practices for Medical Devices: Risk Management

The clients we work with at Sterling Medical Devices often know they want to produce a high-quality medical device, but unfortunately too often do not fully understand an element essential to good...
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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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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

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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