LEXQARA

LEXqara has been created after 6 years of industrial experience in Quality Assurance and Regulatory Affairs with small, medium and large medical device manufacturers (e.g., Integra or Covidien) and 9 years of consulting experience in major consulting firms such as Emergo by UL or Cactus Life Sciences. Lex supports medical device manufacturers and provides quality and regulatory consulting including but not limited to QMS audit (ISO 13485, QSR) and implementation; technical documentation / NBOp / 510(k) compilation; PMS/PMCF; clinical evaluation (CEP/CER) and SSCP; design control; risk management; general regulatory consulting (e.g., UDI, classification, bundling); trainings (under demand).