We want to contribute to the medical progress
About LEXQARA

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.

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

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.

Lexqara logo on blue background

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.

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 Experience

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

Alexandre Petiard
10 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
10 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, 1 year of consulting Cactus, LEXQARA
4 years with EU requirements
1 year with PMS and PMCF activities
4 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

What our customers say

Because we value your opinion.