JALEX Medical, LLC
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Regulatory AffairsDescription
Westlake, OH 44145-1185
JALEX Medical, LLC offers medical device design, product development, and regulatory consulting. Device design capabilities include concept generation, design for manufacturability, material selection, and prototype development. The company's range of regulatory services include ISO 13485 training, internal/supplier auditing assistance, FDA risk assessment, and assistance with 510(k) submissions, regulatory documents, product classifications and continuous education to clients on regulatory changes.
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