Westlake,  OH 
United States

Development Engineering, Regulatory, & Strategic Consulting.

JALEX Medical offers a one-stop shop when it comes to Class I & Class II product development & regulatory services.  Our team of biomedical engineers, regulatory & quality management specialists all work under one roof to provide your organization with a streamlined & client centered approach to commercialization.  We are dedicated to organizations with big ideas but who are short on resources to bring their innovation to market.

Design & Development - Concept Generation and 2D/3D CAD - Medical Device Design per FDA regulations - Creation of Prototypes and Production Components - Verification & Validation

Regulatory -  Regulatory Path Assistance & Product Classifications (Class I, II) - 510(k) Submissions - Predicate Device Research - Device/Instrument Registration & Listing - UDI Support

Quality Systems - Quality Management System Development and Implementation per 21 CFR 820 - ISO 13485, MDR, and Canadian Directive - Company Representative during external audits by Regulatory and Third Party Auditors - FDA remediation assistance for 483 observations, warning letters, and consent decrees

Brands: Engineering, Design, Regulatory and Quality Management Specialists.

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