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).
Company Details
- Employees
- 2
- Founded
- -
- Address
- 19 Rue Du Puits, Pouilley Les Vignes,25115,france
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Keywords
- Medical Devices, Regulatory Consulting, Quality Audit, Quality Management System, 510(k), De Novo, 513(g); QSub, Technical Documentation, PMCF Activities, PMS Activities, Clinical Evaluation, SSCP, NBOp, Risk Management, Design Control, Audit & Inspection Support, Trainings, Regulatory Strategy, UDI and Bundling, ISO 13485, ISO 14971, ISO 10993 series, QSR, MDSAP.
- HQ
- POUILLEY LES VIGNES
Lexqara Questions
Lexqara's LinkedIn profile is https://fr.linkedin.com/company/lexqara
Lexqara has
2 employees.
View email and phone details for 2
employees at Lexqara.
Lexqara's industry is
Medical Equipment Manufacturing
Lexqara's top competitors are
Imdr Medtech,
Svas Biosana,
Rcts,
Mediteck Medical Technologies,
Edwards Lifesciences,
Farmac - Zabban S.p.a.,
Osteocare Medical,
Alsa Apparecchi Medicali Srl,
Plastod S.p.a.,
Emergo By Ul.
Lexqara's categories are Medical Equipment Manufacturing
Lexqara's founding year is 2023
