JALEX Medical- Device Development & Regulatory Services
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: Regulatory consulting, Device development, Regulatory, UDI, QMS, quality management system audits prototyping, FEA, 510k, design engineering, Device consulting, FDA clearance.