Consulting and Assistance in Quality and Regulatory Affairs in the field of medical devices
Personalized and operational support from start-up to market launch.
Welcome
Med'In QARA - We offer customized and operational support to medical device manufacturers, from the creation of your company to the market lauch of your devices, as well as assistance in managing your routine Quality and Regulatory Affairs activities, whatever the size of your company.
My goal: To guarantee the quality, compliance and safety of devices, for the peace of mind of our customers.
Stéphanie GARBEZ
Founder of Med'In QARA and Consultant
With a degree in materials engineering, biomaterials and quality control in the healthcare industry, I have dedicated almost 25 years of my career to the quality and compliance of medical devices, in the interests of patient safety. My career has included operational roles and/or responsibilities within Notified Body, testing laboratories and industrial groups. In view of the many challenges facing the sector, I founded Med'In QARA to provide you with structured, pragmatic support and put 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?
When you choose Med'In QARA, you are assured of quality support that optimizes your resources, time and costs. Med'In QARA helps you structure your processes efficiently, anticipate and resolve non-conformities, and manage documentation to meet the most stringent standards and regulations.
My approach guarantees greater reliability of your quality system and regulatory files, ensuring consistency and traceability of essential information. This commitment to quality and compliance enhances the safety of your devices and the satisfaction of your customers, while minimizing risks during audits, inspections and assessments.
With Med'In QARA, you gain peace of mind: structured, personalized support makes it easy to navigate the complex regulatory framework of the medical device industry. My goal is to help you focus on your core business, by providing you with concrete solutions tailored to your needs.
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