Quality and regulatory advice for medical devices
Operational and customizedsupport for medical device manufacturers.
Welcome
Med’In QARA – This is operational and personalized support inQuality and Regulatory Affairs, offered to medical device manufacturers from the creation of the company to the marketing of the product, as well as assistance in managingpost-marketing activities, regardless of the size of the company.
My goal: To guarantee the quality, compliance, and safety of devices for everyone's peace of mind.
Stéphanie GARBEZ
Founder of Med'In QARA and Consultant
With a degree in materials engineering andbiomaterials, I have devoted my 25-year career to the quality and compliance of medical devices, working to ensure patient safety. My cross-functional background includes operational and management roles withinnotified bodies, testing laboratories, and industrial groups.
Faced with the many challenges facing the sector and to compensate for a lack of qualified resources, I created Med'In QARA to offer you structured and pragmatic support, putting my expertise at your service.
Together, we build effective solutions to meet quality and regulatory requirements and ensure the success of your projects.
Med'In QARA - The partner who simplifies your success.
Areas of intervention
Quality Management
Med'In QARA helps you set up and manage your Quality Management System (QMS) in accordance with ISO 13485, for ongoing compliance. From initial certification to regular monitoring, every step is designed to enhance the efficiency and quality of your processes.
Regulatory Compliance
Whether you're targeting the European or international market, Med'In QARA can help you comply with applicable regulations(Regulation (EU) 2017/745, QSR 21 CFR...).
To this end, I develop your strategy for smooth and efficient compliance.
Design and Development
Med'In QARA helps you structure your Design & Development process. From idea to Design Transfer, I'll help you create the documentation and implement thepre-clinical and clinical investigations protocols needed to guarantee device safety and performance.
Clinical evaluation
In partnership with MedTech SMEs, Med'In QARA provides you with solutions and dedicated support to implement your clinical evaluation process, from setting up the Clinical Evaluation Plan (CEP) to writing the Clinical Evaluation Report (CER).
Process and Software Validation
Med'In QARA supports you in the validation of your manufacturing processes and software, following rigorous, reliable protocols and ensuring compliance with standards and guides. This process covers the preparation of documentation, testing and follow-up of each validation.
Control and testing laboratories
To guarantee appropriate, reliable testing and quality control, Med'In QARA applies the principles of ISO 17025 to your in-house laboratory. Every step, from documentation to method validation to COFRAC accreditation (if required), is structured to ensure the accuracy and traceability of results.
Executive support
For industry leaders, Med'In QARA offers strategic support in drawing up business plans and due diligence audits. I help leaders make informed decisions for a structured and secure development of their company.
Why choose Med'In QARA?
With Med’In QARA, I can easily put into words what drives me: using my solid operational expertise to transform the complexity of the quality and regulatory requirements inherent in medical devices into a clear, controlled, and effective framework.
In this role, I serve as a facilitator for executives by managing regulatory challenges: I free up their energy and unlock their potential for growth. My goal is simple: to enable them to focus fully on what drives their company’s value— strategy,innovation, and growth.
I also work alongside QARA managers and teams as an additional expert resource, bringing a systematic approach, objectivity, and efficiency to the management of regulatory requirements and their quality system. My approach helps lighten the teams’ workload while ensuring the organization’s long-term stability.
With Med'In QARA, whether you are a QARA executive or a QARA practitioner, you can enjoy greater peace of mind while staying focused on your core business and your goals.
