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Benno Henry

Benno Henry

Quality Manager

Quality Manager Benno Henry has over 14 years of engineering and quality assurance experience in the medical device industry. She specializes in ensuring Sterling’s processes and procedures adhere to industry standards and result in high-quality, compliant products for its customers. Ms. Henry is a certified ISO 13485 internal auditor and has extensive experience as a test engineer. She provides QA review of project documents to ensure compliance with procedures. She is also heavily involved in guiding and mentoring system test engineers, supporting them through developing training materials, conducting regular meetings and troubleshooting challenges with writing requirements and test protocols, following best documentation practices for testing compliance. Ms. Henry earned her Bachelor of Engineering degree in Electronics and Communication Engineering from Dayananda Sagar College of Engineering. She strives to achieve excellence in every project she works on and is passionate about mentoring fellow engineers and implementing process improvements to achieve that goal. 

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Resources

FDA medical device regulations graphs.

April 4, 2022

FDA Medical Device Regulation Guidance for 2022

In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released...
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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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July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
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