ConceptDesign & DevelopmentVerification and ValidationRegulatoryQMSProduct Launch
Biomedical design engineers to support you from initial concept through every stage of development.
Guidance to assist you in meeting every standard and regulation to secure your pathway to success in the US or abroad.
Guidance to define your quality objectives and develop the deliverables to integrate quality into all facets of your project.
Professional second opinion to get your medical device project back on track.
“We’re committed to building relationships of the highest level of quality and trust, while providing exceptional value to our clients. From large corporations to small startups, their success is ours.”
- Jennifer Palinchik, President
At JALEX, we realize how important your development project is to the success of your company. Our team will execute your project from concept through commercialization. We provide a unique one-stop-shop approach to your development needs. Our biomedical engineers are trained in a variety of expertise, such as Orthopaedics, Spine, Ophthalmology, Dental, Urology, General Surgery, and more. We will assist you with your regulatory requirements and technical documentation and provide your company with a customized quality management system best suited for your business model. No project is too large nor too small. We welcome all opportunities and look forward to collaborating with you. Contact us today.
Omnia Medical, LLC. received FDA 510(k) clearance to market this first of its kind PEEK-OPTIMA™ HA Enhanced “Omnia Medical VBR” on October 26, 2017. The collaboration and partnership with JALEX Medical on product development and regulatory activities along with Invibio’s PEEK-OPTIMA™ HA Enhanced material has led to this advancement and innovative product within the orthopedic sector. The vertebral body replacement system is used in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body.
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