I am the Quality Director at small startup medical device organization. As a small, but growing company with limited resources and often shifting priorities, finding the right consultant to meet our needs can be a challenge. However, LEXqara exceeded our expectations in every way. We worked with LEXqara on drafting the clinical evaluation documentation required for EU MDR certification and conducting a Technical Documentation gap analysis. LEXqara demonstrated exceptional knowledge of the EU regulatory landscape, providing insightful guidance and ensuring that our documentation met stringent EU MDR requirements. His ability to identify and address gaps in our Technical Documentation helped us avoid potential setbacks. LEXqara worked seamlessly with us, adapting to our evolving priorities while ensuring all deadlines were met without compromising quality. One of LEXqara's strengths was their excellent writing skills, which were evident in the polished and professional clinical evaluation documentation (CEP, CER, PMS, SSCP) prepared for us. We greatly appreciated their flexibility, collaborative approach, and their technical knowledge. I highly recommend LEXqara to any organization seeking a skilled and reliable consultant, particularly in the areas of EU regulatory compliance, Technical Documentation and QMS gap analysis, and EU MDR documentation preparation.

J'ai collaboré avec la société Lexqara dans le cadre d'audit interne ISO13485/MDSAP ainsi que pour des audits fournisseurs. Je suis totalement satisfaite de la prestation réalisée, et de la qualité des rapports fournis. Alexandre est un auditeur expert et sérieux, comprenant les problématiques règlementaires et industriels. Je recommande fortement. Pascale, Q&RA Director

LEXQARA est intervenu pour notre audit interne (ISO 13485). A l'écoute de nos besoins, a tenu compte de nos spécificités et nous a même conseillé sur des exigences MDSAP (certification que nous visons à longs termes). Je recommande. F. PAUPERT Directeur QARA Aurora Sterilisation

Nous avons collaboré avec Lexqara dans le cadre de formations à l'ISO 13485 et aux techniques d'audit. Nous sommes très satisfaits de cette collaboration qui a permis aux initiés de connaitre les exigences et aux confirmés d'approfondir leurs connaissances. Alexandre sait parfaitement s'adapter aux demandes de l'entreprise et est très réactif.

In the scope of our UK QMS certification preparation activities, we have worked with LexQARA, with Alexandre Petiard, for an internal audit conduct. The collaboration was constructive and professional, and leaded to great outcome. The auditor showed a solid understanding of the scope, valuable skills in Quality and regulatory domain and pedagogical methods in auditing. Happy with the outcome of our collaboration. Maria EL KALLAB Senior EMEA Quality System Manager (ResMed, UK).

Nous remercions la société LEXqara et plus particulièrement Monsieur Alexandre Petiard d’avoir apporté son expertise en qualité et affaires réglementaires dans le cadre de projets au sein de la société ennoïa. Benjamin Billottet, Fondateur ennoïa