JALEX Medical, LLC
Chhavy Tep-Cullison has extensive experience in regulatory affairs in the medical device industry. Currently working at JALEX Medical, LLC as a Regulatory Affairs Specialist, Chhavy is involved in medical device design, product development, and regulatory consulting, ensuring compliance with FDA regulations. Previously, Chhavy worked at NovelMed Therapeutics as a Regulatory Affairs Scientist. With a background in biochemistry, Chhavy holds a Bachelor's degree from Case Western Reserve University, a PhD from The Ohio State University, and completed a Postdoctoral Fellowship at Stanford University.
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JALEX Medical, LLC
JALEX Medical is a privately held design, engineering, and product development firm headquartered in Westlake, just west of Cleveland, Ohio. Our highly experienced team has helped hundreds of clients bring innovations to market since 2012. With an emphasis on Class I and Class II devices, JALEX offers unrivaled support and expertise in bringing your idea from Concept to Commercialization. Additionally, our team provides a la carte professional support and expertise throughout design, verification, validation, regulatory, and QMS development phases. Every member of JALEX’s medical device consulting team specializes in his or her department but has thorough cross training in all aspects of the medical device development process. As a result, the team brings tremendous value to our clients by providing all the services you need under one roof. Services include: - Medical Device Design - Regulatory Affairs - Quality Management Systems - Project Management - Project Rescue Areas of Expertise: - Cardiology - Dental - ENT - Gastroenterology - General Surgery - Neurological - Ophthalmology - Oral and Maxillofacial - Orthopedics - Pain Management - Pediatrics - Podiatry - Plastic Surgery - Pulmonology - Radiology - Spine - Upper and lower extremity - Urology - Vascular