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About LEXQARA

Our vision is to support medical device manufacturers, with a special focus on MedTech startups, through practical QA/RA and clinical solutions that are easy to understand, easy to use and directly applicable. We believe companies need concrete tools more than unnecessary complexity, so our approach is built around clarity, practicality and efficiency. We want to make your life easier.

What our customers say

Because we value your opinion.

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5 entries.
Maria EL KALLAB wrote on November 27, 2025
Nous avons travaillé avec LexQARA sur une formation MDR personnalisée dans le cadre des activités des importateurs /distributeurs, y compris les exigences réglementaires de la Suisse et UK pour les dispositifs médicaux. C’était une formation enrichissante, dynamique et très adaptée. LexQARA a montré encore une fois un haut niveau de compétences et de professionnalisme.
Jaroslaw Masiak wrote on October 3, 2025
Working with Lexqara has been an excellent experience. Their professionalism, expertise, and outstanding organization in preparing our clinical evaluation and PMS documentation were crucial for the successful acceptance by the Notified Body. We truly value their support and can highly recommend Lexqara as a reliable and competent partner. Jarosław Masiak Echo-son s.a.
Etienne Moolman wrote on May 6, 2025
LexQARA supported our business with a full ISO 13485:2016 QMS Internal Audit here in the UK. It was a great experience, we learnt more about our system and can highly recommend their services.
Petruţa Aelenei wrote on March 18, 2025
My name is Petruţa Aelenei, I am a pharmacist working in Regulatory Affairs. Using the templates from Lexqara, I was able to update TD for medical devices and all updates were accepted by Notified Body. Thank you for resources – they have truly made a significant difference in my work! Petruţa
Sabrina SAMSON wrote on March 4, 2025
Formation Inspection FDA très enrichissante intra entreprise, qui a su enrichir nos connaissances et nous stimuler lors du cas pratique.

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.

Discover LEXQARA
alexandre-petiard-v3
Alexandre Petiard
President & QA/RA Consultant
nandini-v4
Nandini Dhiman
QA/RA Consultant
rehema-mussanzi-v2
Rehema Mussanzi
Business Development Manager
About LEXQARA

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.

Alexandre Pétiard
President & QA/RA Consultant

Our mission

At LEXQARA, “LEX” embodies 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.

Lexqara logo on blue background

At LEXQARA, we believe compliance should be built with consistency, not with disconnected documents and isolated decisions. Our approach is to help medical device manufacturers create a clear and coherent path by connecting quality, regulatory and clinical activities from the early stages of development. We focus on practical execution, realistic priorities and solutions that can evolve with the maturity of the project, so companies can move forward with greater clarity and confidence.

Our Experience

LEXQARA has currently a cumulative 20 years of experience in quality and regulatory affairs.

Alexandre Petiard
12 years of consulting Emergo by UL, Cactus, LEXQARA
>15 years with EU requirements and >10 years with US requirements 50+ TD, 3+ 510(k)
15 years with clinical activities 50+ CER, 20+ CEP, 5+ SSCP
15 years with risk management activities 20+ risk management files
12 years of audit 50+ audits (including MDSAP)
>10 years of regulatory strategy Gap analysis with EU (15+), US (10+), global (5+) requirements
5 years with PMS and PMCF activities 5+ PMS plan, 5+ PMS report/PSUR, 5+PMCF plan, 5+ PMCF Evaluation Report
Nandini Dhiman
3 years of medical writer, 2 years of consulting Cactus, LEXQARA
4 years with EU requirements
2 years with PMS and PMCF activities
5 years with clinical activities
Rehema Mussanzi
Over 10 years of experience working in business development for medical devices Emergo, Executive Director of Centre Résolution Conflits, 1MED, Lepaz
Consulting services EU MDR & IVDR related services, FDA services, Quality System & Risk Management Services
Registration & in-country representation services Markets globally covering Europe, North America, South America, Asia, and Oceania
Market scan and distributor search services