Our Quality Management System documents or our Lex ebooks aim at the simplification of your daily work. Download, use, modify our templates, procedures and contact us if you need our expertise, support or training.
Our LEXQARA
team
Our dedicated experts leverage extensive knowledge and commitment to quality to support our clients. We ensure regulatory compliance and focus on your needs to deliver effective solutions and drive your success.
Our mission
At LEXQARA, “LEX” embodies our core values:
Lex represents our core values:
Compliance
Our team of highly qualified QA/RA consultants brings extensive experience in managing complex projects to ensure regulatory adherence.
Simplification
We are dedicated to continuously developing documents and tools designed to streamline and simplify your daily work processes.
Lex means law in Latin and we are experts in medical device compliance. Through our large experience and will to maintain our competences, Lex delivers a broad panel of services to support manufacturers with their quality or regulatory concerns.
The acronym “LE” (Life Easier) in our logo symbolizes our mission to simplify the complexities of the highly regulated medical device environment. Our developments are designed to streamline the daily work of regulatory and quality specialists. What does this mean in practical terms? We provide continuously updated free quality and regulatory templates, and develop LEX ebooks to elucidate requirements, address risks, and offer essential recommendations, thereby enhancing the predictability of success for our clients.
With over 15 years of experience in the medical device industry and consulting, I founded LEXQARA, a QA/RA consulting company, to deliver high-quality expertise and provide effective tools designed to streamline the daily operations of QA/RA professionals.
Our Experience
LEXQARA has currently a cumulative 20 years of experience in quality and regulatory affairs.
What our customers say
Because we value your opinion.
Qi Liu2025-01-02 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. Pascale LAGRANGE2024-12-12 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 Florian Paupert2024-10-13 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 justine Bourgeois2024-09-26 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. maria kallab2024-09-16 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). benjamin billottet2024-09-10 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 ennoïaGoogle rating score: 5.0 of 5, based on 3 reviews