Artificial intelligence, designed by human expertise.
My Audit Corner didn't emerge from a Silicon Valley lab, but from the field. Facing the growing complexity of medical device regulation, we decided to create the assistant that RA/QA teams desperately needed.
From frustration to innovation.
As former quality managers and regulatory affairs experts, we lived through the transition to MDR (2017/745) and IVDR (2017/746) regulations firsthand. We experienced sleepless nights before external audits, endless document reviews to verify a single cross-reference, and exorbitant costs for medical device consulting.
Regulatory requirements are essential for patient safety, but the verification method is proven. We needed a tool capable of absorbing the complexity of ISO 13485 at machine speed, while maintaining the rigor auditors demand. My Audit Corner was born from this vision: liberating humans from document burden to refocus on strategy.
Your peers. Your experts.
An AI assistant's effectiveness depends on those who train it. MAC's algorithm was structured by a trio of engineers with unique dual expertise in technology and regulatory affairs. Having already founded, certified (MDR IIa), and sold a Medtech startup (Doc2U, acquired by Biosynex in 2022), and survived over 12 audits as auditors or auditees, they know your challenges intimately.
Sébastien Risler
CEO & Co-founderECE Paris engineer with 15 years of experience. Former R&D and Regulatory Affairs Director at Biosynex, Sébastien brings sharp strategic and market vision. Having overseen numerous CE markings, he brings the methodological rigor required by Notified Bodies to MAC's AI.
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Aymeric Malle
CTO & Co-founderUTBM engineer with 15 years of experience in critical B2B SaaS software architecture. Aymeric is the technical guarantor of our solution. He deploys MAC on highly secure cloud infrastructure, protecting your sensitive data to cybersecurity standards.
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Charles Risler
CAIO (Chief AI Officer) & Co-founderENSEEIHT engineer, dual expert in Artificial Intelligence (RAG architectures) and regulatory affairs (QA/RA). Charles translates ISO 13485 rigor into precise algorithms, giving your QMS software (eQMS) an infallible analytical mind.
View LinkedIn profileHumans decide, machines prepare.
We firmly believe artificial intelligence will never replace a regulatory affairs manager. However, a RA/QA manager assisted by AI will outperform one working alone. Our mission is to provide you with a devoted, tireless, and precise assistant so you regain control of your time and QMS software (eQMS).
Build the future of Medtech compliance together.
Are you an RA/QA engineer passionate about innovation or a full-stack developer ready to revolutionize healthcare? MAC is growing fast and we're hiring top talent.