JALEX Medical, LLC

medical devices

About

JALEX Medical, LLC is a design, engineering, and product development firm based near Cleveland, Ohio. Founded in 2012, the company specializes in custom product development for the medical device industry, focusing on Class I and Class II devices. Their team consists of biomedical and mechanical engineers, regulatory affairs specialists, and quality management experts, providing extensive support throughout the medical device development lifecycle. The firm offers consulting services aimed at expediting the market readiness of medical innovations. Their services include medical device design, regulatory affairs assistance, quality management system support, project management, and project rescue. JALEX Medical collaborates with various medical device companies, helping them navigate product design, regulatory compliance, and quality assurance across multiple surgical specialties. The company is also active in the local engineering community, holding memberships in organizations like BioOhio and the Cleveland Engineering Society.

Technologies

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Keywords

medical devices regulatory affairs quality management systems 510 submissions unique device identification biomedical engineering fda orthopedics product development project management project rescue medical equipment manufacturing compliance with us and international standards medical device development design verification verification and validation regulatory consulting quality assurance manufacturing support b2b device design engineering iso 14971 cross-disciplinary engineering team fea analysis vendor management prototyping manufacturability iso 13485 product testing post-market surveillance support

Location

27865 Clemens Rd, Westlake, Ohio, United States, 44145-1114

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