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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.
RTsafe, with collaboration from JALEX Medical, gets 510(k) FDA clearance for Personalized PseudoPatient™. For the first time in the US, therapists can safely simulate and verify an individual radiotherapy treatment cycle before exposing the patient suffering from brain cancer to potentially harmful radiation.
The PseudoPatient™ dosimetry phantoms, built from real patient anatomical data, combine proven expertise in medical physics with highly accurate 3D printing technology for radiotherapy treatment.
JALEX Medical partnered with the Greek based company in 2017 as their United States based regulatory consultants. RTsafe came to Ohio via the "SelectUSA" program, which is a division of the United States Chamber of Commerce aimed at bringing medical device companies to the United States. JALEX Medical's president, Jennifer Palinchik, participated as a featured speaker and mentor during the Cleveland event.
“It’s exciting to see the continued advancements that are being made in the medical industry with 3D printing, and the PseudoPatient™ device is yet another example of brilliant forward thinking that can improve outcomes for many cancer patients.” Jennifer Palinchik, President of JALEX Medical
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