Consulting and Assistance in Quality and Regulatory Affairs for medical devices
Personalized, operational support from start-up to market launch.
Welcome
Med'In QARA - We offer customized, operational support for medical device manufacturers, from company start-up to the marketing of your devices, as well as assistance in managing your routine quality and regulatory activities, whatever the size of your company.
My aim: to guarantee the quality, conformity and safety of our 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 devoted nearly 25 years of my career to the quality and compliance of medical devices, in the service of patient safety. My career has included operational roles and responsibilities within notified bodies, testing laboratories and industrial groups. Faced with the many challenges facing the sector, I created Med'In QARA to offer you structured, 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 ISO 13485 Quality Management System (QMS), 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 regulations such as EMDR 2017/745 or QSR 21 CFR in the United States. I'll develop a tailor-made strategy for smooth, efficient compliance.
Design and Development
From idea to validation, Med'In QARA supports your teams in structuring the Design & Development process for your devices. This includes creating documentation and thinking about the tests needed to guarantee safety and performance.
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. This process covers documentation, testing and follow-up of each validation.
Control and testing laboratories
Med'In QARA lays the foundations for certification of your in-house laboratory to ISO 17025, guaranteeing appropriate and reliable testing and quality control processes. Every step, from documentation to COFRAC accreditation (optional), is structured to ensure the accuracy and traceability of results.
Executive support
For industry leaders, Med'In QARA offers strategic support in transition management, business plan development 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 you greater reliability of quality and regulatory records, by 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 and inspections.
With Med'In QARA, you also gain peace of mind: structured, personalized support enables you to navigate the complex regulatory framework of the medical device industry with peace of mind. My aim is to keep you focused on your core business, by providing you with concrete solutions tailored to your needs.
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