Mason Makulinski's Colleagues at JALEX Medical
Mason Makulinski's Contact Details
Westlake, Ohio, United States
JALEX Medical
Mason Makulinski's Company Details
JALEX Medical-Bringing medical innovation to market with small companies that think big. JALEX Medical provides- fee for service class I &II development & regulatory services out of their Cleveland, Ohio office. Exceptional attention to detail and customer service with over 18 years of experience bringing device innovation to market. Based on industry averages, companies who used our services experienced • 29% faster development time• 47% faster 510(k) clearance "What makes JALEX unique is that the program management, engineering, and regulatory teams work together under one roof to expedite the medical device development process. In many cases, we have demonstrated quicker to market wins compared to industry standard percentages. - Jennifer Palinchik- President LIST OF CAPABILITIES: • Concept Generation• 2D/3D CAD Modeling• Design for Manufacturability• Engineering Analysis – FEA• Material Selection• Rapid Prototyping (3D printing)• Risk Assessment• Regulatory Pathway• 510(k)s• Post-launch regulatory support• QMS development• Compliance auditing• 21 CFR 820 • ISO 13485, ISO 9001• UDI (Unique Device Identification) Areas of Expertise• Orthopedics• Neuro/Spine• Urology• General Surgery• Ophthalmology To learn more about how JALEX Medical can better services your projects, please reach out today. Contact:440.541.0060 info@jalexmedical.com