LEXQARA Logo - medical devices

LEXQARA

medical devices
China's Best One-Stop Medical Equipment Provider
About

LEXQARA is a consulting company specializing in Quality Assurance and Regulatory Affairs (QA/RA) for the medical device industry. Founded by an experienced professional, the company focuses on simplifying regulatory compliance for manufacturers. With over 20 years of cumulative expertise, LEXQARA provides essential services and tools to help clients navigate complex regulatory environments. The company offers a variety of consulting services, including the preparation of Post-Market Surveillance plans, Periodic Safety Update Reports, and Post-Market Clinical Follow-up evaluations. LEXQARA also develops Quality Management System (QMS) documents, templates, and procedures that clients can easily download and modify. These resources aim to streamline the development of regulatory documentation and enhance operational efficiency. LEXQARA's mission is to support medical device manufacturers of all sizes by providing expert guidance and practical tools. Their continuously updated templates and procedures help clients maintain compliance with regulatory requirements while improving their quality management processes.

Keywords
trainingsiso 14971technical documentationregulatory strategymedical devicespmcf activitiesrisk managementudi & bundlingpms activitiesquality auditquality management system510de novo513 qsubsscpaudit inspection supportclinical evaluationnbopiso 10993 seriesmdsapiso 13485regulatory consultingdesign controlqsrmedical equipment manufacturinghospital & health care
Company Information
  • Employees2
  • Founded2023
Location

19 Rue du Puits, Pouilley-les-Vignes, Bourgogne-Franche-Comte, France, 25115

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