Author: Dan Sterling | Date: October 29, 2020
MOONACHIE, NJ — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, is pleased to announce the renovation of their Regulatory Affairs Department that will now focus on providing strategic guidance and collaboration for complying with applicable regulatory requirements and implementing industry best practices across the board. We are now able to provide specialized advice to companies through their entire journey – from nascent proof-of-concept to developing practical strategies for clinical trial design, and product development to seeking regulatory approval and managing product life cycles. This new department will be led by newly hired Carrie Hetrick as the Director of Regulatory Affairs and Tara Miller, Manager of Human Factors and Clinical.
Collectively, Carrie Hetrick and Tara Miller bring more than 40 years of industry excellence. Before joining the Sterling Medical Device team, Hetrick’s knowledge in organizational structure and responsibility requirements for medical device regulations, administrative and legal requirements led to over 90 complex FDA regulatory submissions. Hetrick’s extensive experience includes countless quality system implementation and transitions, premarket review, and post-market program enforcement (e.g., Warning Letters, 483 Responses, FDA Inspectional Programs, Clinical Evaluation Reports, and Post Market Clinical Follow-up).
Respectfully, Miller is a sought-after medical device expert who served as a senior consultant for regulatory and clinical affairs where she oversaw the clinical development and clinical research efforts of over 30 partner collaborators. Under Miller’s leadership, Zynex Medical grew from a start-up into a prominent neurostimulation company.
“Our commitment to advancing and streamlining our regulatory services including preparation of submissions and product development is top priority as we continue perfecting our global compliance program,” said Dan Sterling, President of Sterling Medical Devices. “The new department will help to support our strategic partnerships, while also streamline the upcoming projects and engineered innovations.”
The Expanded Regulatory Affairs Department will also be a resource on collaborated projects and relationships. Most recently, Sterling Medical Devices worked alongside HS Design on the development of Healight™ investigational devices, a potential treatment of critically ill patients infected with COVID-19. A partner for several years, HS Design is an ISO 13485 certified user-centered design firm commitment to design excellence, and strong client partner relationships have yielded over 400 successful products and multiple international design awards.
“We are extremely pleased Sterling Medical Devices and HSD could work together to provide a potential impact to fight COVID-19,” said Tor Alden, Principal at HS Design. “We are looking forward to continuing the important work on the advancement of the Healight™ device and its use in the investigational clinical studies.”
In addition to expanding the capabilities of the newly redesigned regulatory affairs department lead by Hetrick and Miller, Sterling Medical Devices continues their initial growth with the involvement of exciting new engineering projects in the works.
Sterling is spearheading the design and build of several prototypes of upcoming innovations.
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