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JALEX Medical assists with the verification and validation processes, ensuring the performance and safety and effectiveness of the product meets FDA requirements. This process includes design control documentation, risk assessments, sterilization and packaging, mechanical testing, and process validation.![]()
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Company
JALEX Medical
Headquarters
Westlake, Ohio
Management
Jennifer Palinchik, President
Description
JALEX Medical offers product development, design engineering, regulatory affairs, and quality management solutions along with the expertise of its biomedical engineers to support clients in the medical device industry through every stage of the development process.. The company provides step-by-step directives to startups to take their product from ideation to fruition. It works on the process of 3D CAD modeling, finalizing the materials and the manufacturing process, and then prototyping the product for client approval. It further works on the verification and validation process, after which it helps clients acquire clearance on their products to go to market. JALEX Medical works as an extension of the clients’ engineering and regulatory department while supporting them throughout the roll-out process
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