Samuel Fang
Principal Consultant, Regulatory affairs Certification (RAC) at Device regulatory consultant (FDA 510k) | The Colony, Texas, United States
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Samuel Fang is a distinguished Principal Consultant in Regulatory Affairs, specializing in the intricate landscape of medical device regulations, particularly the FDA 510(k) submission process. With a robust academic foundation, holding a Ph.D. in Mechanical Engineering and a Master's in Regulatory Affairs, Samuel merges technical expertise with regulatory acumen, making him an invaluable asset to medical device startups navigating the complexities of product development and market entry.
In his current role, Samuel provides strategic consulting on quality and regulatory frameworks, helping emerging companies streamline their pathways to FDA clearance. His extensive experience encompasses a diverse array of medical devices, including trauma plates, pedicle screws, and total hip and knee implants. Samuel’s proficiency in design control, biomechanics, and mechanical testing underpins his ability to guide clients through the rigorous demands of ISO 13485 compliance and the FDA's regulatory landscape.
Samuel is particularly adept at employing design of experiments (DOE) methodologies to optimize product performance and ensure that devices meet stringent safety and efficacy standards. His insights into orthopedic device development are complemented by a thorough understanding of biomedical engineering principles, allowing him to address both the engineering and regulatory challenges faced by his clients. As a trusted advisor, Samuel Fang not only facilitates successful 510(k) submissions but also empowers startups to innovate responsibly, ensuring that their products are both market-ready and compliant with industry standards.
Principal Consultant, Regulatory affairs Certification (RAC) at Device regulatory consultant (FDA 510k) in June 2018 to Present
Sr. Engineering Manager at Orthofix in January 2020 to July 2021
Engineering Manager at Orthofix in January 2017 to December 2019
Staff Engineer at Orthofix in January 2012 to December 2016
Sr. Project Engineer at Orthofix in November 2010 to December 2011
Sr. R&D Enginner II at Zimmer Spine in August 2008 to October 2010
Sr. R&D Engineer I at Zimmer Spine in October 2005 to August 2008
Research Assistant/Adjunct Instructor at Drexel University in September 2001 to September 2005
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Finite Element Analysis
Biomaterials
Design Control
Biomechanics
Medical Devices
Mechanical Testing
R&D
Regulatory Affairs
Orthopedic
Validation
ISO 13485
Design of Experiments
FDA
Biomedical Engineering
Orthopedics
Design for Manufacturing
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What is Samuel Fang email address?
Email Samuel Fang at [email protected] and [email protected]. This email is the most updated Samuel Fang email found in 2026.
How to contact Samuel Fang?
To contact Samuel Fang send an email to [email protected] or [email protected]. (updated on October 31, 2024)
What company does Samuel Fang work for?
Samuel Fang works for Device regulatory consultant (FDA 510k)
What is Samuel Fang's role at Device regulatory consultant (FDA 510k)?
Samuel Fang is Principal Consultant, Regulatory affairs Certification (RAC)
What is Samuel Fang's Phone Number?
Samuel Fang's phone (214) ***-*924
What industry does Samuel Fang work in?
Samuel Fang works in the Medical Equipment Manufacturing industry.
Samuel Fang Email Addresses
Samuel Fang Phone Numbers
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