Right support for success
Our engineering team brings deep expertise in Medtech standards, with specialized experts ready to support you at every stage—from concept to market.
David
Enfrun
Executive Medtech
Engineer
Manufacturing
Industrialization
Management
More about David
David Enfrun brings adaptable expertise and strategic insight to MedTech ventures of any focus.
With over 25 years in the medical device industry, David has extensive experience across the entire product life cycle—from development and engineering to manufacturing, quality, and supply chain management. Known for his strong, « can-do » leadership, he’s been a pivotal figure in MedTech startups, excelling in executive roles.
He has successfully led scale-ups, secured regulatory compliance for Class III devices, co-founded a venture, and managed partnerships in contract design and manufacturing. Holding an engineering degree and advanced training.
He brings specialized expertise to drive growth and innovation for small organizations across the medical technology industry.
Marylise
Robert
Executive INDEPENDANT
CONSULTANT
Quality
Regulatory
Clinical
More about Marylise
Marylise Robert brings over 7 years of industry experience, specializing in regulatory compliance, quality assurance, and clinical oversight for medical devices.
With a Biomedical Engineering background, she has achieved multiple CE marks for Class I, IIa, IIb and III, overseen MDR transitions, and implemented QMS for III devices across various fields, including cariodlogy, orthopedic and biopolymer-based products. Known for her adaptability and problem-solving skills, she consistently aligns quality processes with business objectives to deliver safe, compliant products.
Her commitment to anticipating regulatory changes makes her an invaluable partner for growth-focused MedTech ventures.
Loane
Dousset
Junior Medtech
Engineer
Qualification
Validation
Technical documentation
More about Loane
Loane Dousset brings a solid grounding in medical device compliance and engineering, specializing in Class III devices and ISO 13485 standards.
With a degree in Biomedical Engineering from ISIFC-Besançon, Loane has hands-on experience in regulatory submissions, quality process optimization, and internal audits. She already contributed to Design History Files and strengthened supply chain compliance for medical devices under MDR standards.
Her skills in regulatory documentation, quality assurance, and clinical trial support make her an asset in advancing safety and innovation in medical technology
Aurélien
Maurer
Senior Medtech
Engineer
Conception
Prototyping
Experimentation
More about Aurélien
Aurélien Maurer is a consultant with over a decade of experience, he is a problem-solver at heart, bringing engineering expertise to complex MedTech challenges.
Known for his methodical approach and deep technical skill, Aurélien specializes in concept development, prototyping, and manufacturing.
Whether optimizing industrialization processes or streamlining supply chains, Aurélien leverages a strong R&D background and patent experience to deliver practical, efficient solutions. His consulting support empowers MedTech companies to navigate sophisticated engineering and development issues with confidence
Saray
Ugidos Semán
Senior Independant
consultant
Quality
Regulatory
Clinical
More about Saray
Saray has over 14 years of experience in regulatory compliance, quality assurance, and clinical management of medical devices.
With a background in Economics and Law, she has worked across ophthalmology, cardiology, and dermatology, leading regulatory approvals in Europe and the U.S.
A lead auditor for ISO 13485, she has spent over a decade as a quality consultant, guiding companies through compliance and regulatory challenges.
Germain
Esnault
Senior INDEPENDANT
CONSULTANT
Regulatory
Quality
Design Control
More about Germain
Germain Esnault is an independent consultant with over 15 years of experience in the medical device industry.
With a PhD in Biology, he brings extensive expertise in regulatory compliance for Class II and III devices and drug/device combinations across US and EU markets. His experience covers risk management (ISO 14971), post-marketing surveillance, and design control, as well as pre-clinical testing (ISO 10993, USP 1031) and sterilization processes (EtO, gamma, moist heat).
Known for his rigorous and structured approach, he provides valuable support in regulatory strategy and critical quality processes, ensuring consistency, robustness, and long-term sustainability throughout the product life cycle