Arqe Consulting

Save time, reduce risks, and secure your regulatory project!
Arqe Consulting helps you obtain and maintain CE marking for your software as a medical device (SaMD/SiMD). As a regulatory affairs and quality assurance consultant, we simplify the regulatory process and support your international market entry.

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They trust us

Our expertise

Our skills range from implementing a Quality Management System (ISO 13485:2016) to assisting with regulatory submissions and market entry of your products in various countries.

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Arqe Consulting in a few numbers

Years of experience in quality assurance
and regulatory affairs

CE Markings &
510(K) Submissions

ISO 13485 Certifications

Our approach

Clarify

Make requirements clear and easy to understand.

Simplify

Streamline processes to boost efficiency.

Adapt

Customize solutions to fit your real-world operations.

Comprehensive support

See how we can help you

We guide you through every step, offering simple and pragmatic solutions, whether you’re at the beginning or the final phase of your project.

03 Technical file creation

02 Implementation of the QMS

05 Maintenance and follow-up

01 Pre-audit

04 Submission and market entry

01 Pre-audit

02 Implementation of the QMS

03 Technical file creation

04 Submission and market entry

05 Maintenance and follow-up

What our clients say

At Bioquantis, we are fortunate to be supported by Oumaya in the regulatory quality aspects of CE marking our AI-based software medical device. Oumaya’s thoroughness, in-depth understanding of our solution and ability to structure each stage of the process efficiently are major assets. She plays a key role in enabling us to achieve our regulatory objectives on schedule. A valuable and efficient collaboration!

Yedid Elbez

Cofounder and CTO Bioquantis

I would like to thank Oumaya for her valuable support in ensuring the compliance of the technical file for our Class IIb medical device. Her expertise, thoroughness, and availability were key assets throughout the process. With her support, we were able to successfully and calmly complete this step.
I highly recommend her services !

Btissam AIT HAMMOU

Head of QARA
Groupe CEGEDIM
(RESIP-Claude Bernard)

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