Trusted by
Trusted by
Beyond compliance, faster market access.
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.
The process
Comprehensive support
1
Gap analysis
Comprehensive review of current state to identify regulatory gaps.
2
Regulatory strategy
Define device qualification, classification, and regulatory roadmap.
3
QMS structuring
Build or upgrade ISO 13485 quality system for SaMD.
4
Technical documentation
Develop MDR technical documentation compliant with Annexes II and III.
5
CE submission
Our story
We help companies do better. Not more.
We founded Arqe Consulting after several years in the medical device sector, always noticing the same issue: regulatory and quality assurance are too often seen as a vague, heavy, and costly burden.
Client testimonials
"I had the pleasure of working with Oumaya Ibrahim for three months on a Medical Device Regulation (MDR) technical documentation compliance project. From the outset, Oumaya demonstrated strong expertise in interpreting regulatory requirements and an exceptional ability to organize and structure technical documentation effectively.
Her methodical approach and attention to detail ensured that all required elements met regulatory expectations. She responded quickly to unforeseen challenges and adapted efficiently to changes throughout the project.
Beyond her technical skills, Oumaya is an excellent communicator, which greatly facilitated coordination between internal and external stakeholders. Thanks to her professionalism and dedication, we were able to achieve our objectives within the established timelines.
I highly recommend Oumaya for any assignment related to regulatory affairs and medical device compliance. Her rigor and expertise are valuable assets to any organization."
"At Bioquantis, we are fortunate to have Oumaya support us on regulatory quality aspects for the CE marking of our AI-based medical software. Her rigor, deep understanding of our solution, and ability to efficiently structure each step of the process are major assets."
"I want to thank Oumaya for her invaluable support in ensuring the compliance of the technical file for our Class IIb medical device. Her expertise, rigor, and availability were key assets throughout the process. With her guidance, we were able to complete this step successfully and with confidence."
Articles
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