Consulting and Assistance in Quality and Regulatory Affairs for the Medical Industry
Med'In QARA
I'm Stéphanie Garbez, founder of Med'In QARA, a consulting firm dedicated to medical device manufacturers, whose mission is to ensure that quality, compliance and safety are the foundations of every project.
With nearly 25 years' experience in the medical device industry, I have held a variety of roles, including Audit Manager in a notified body, and Technical Manager in a testing laboratory, for which I obtained two COFRAC accreditations. I have also held positions of responsibility such as Design and Test Laboratory Quality Manager, or Quality and Regulatory Affairs Director, within international groups. These experiences have enabled me to develop in-depth expertise in medical device assessment, audits, QMS and technical documentation management, as well as team management.
My technical training (specializing in Materials Engineering, with a Master's degree in Biological and Medical Engineering), combined with my years in the laboratory, enable me to understand technical constraints and offer comprehensive support. In addition to quality and regulatory aspects, I offer in-depth technical expertise, capable of meeting the specific needs of medical device design and development, and process validation. This dual competence guarantees my customers support that goes beyond compliance, and supports innovation in their projects.
Med'In QARA embodies my values: rigor, listening, and an unwavering commitment to the safety and performance of medical devices. Passionate aboutinnovation and healthcare technologies, I place great importance on human support, working closely with each customer to meet their specific needs. Convinced that quality and regulations are levers for development, I adopt a pragmatic approach to integrating these aspects into each project.
To keep abreast of developments in standards and practices, I invest actively in continuing training. I also belong to networks of auditors, assessors and consultants in the sector. In this way, Med'In QARA offers constantly updated support, both in Europe and internationally.
Intervention zones
Med'In QARA can operate both in France and internationally, whether you're located in Europe, the USA, Asia... This international reach enables us to meet the needs of customers in different markets, and adapt strategies to suit local requirements.
Medical Devices Evaluated
Throughout my career, I've had the opportunity to work on a wide variety and class of medical devices, from medical beds and orthopedic implants to vascular and perfusion devices. These experiences have enabled me to develop comprehensive expertise on devices from Class I to III, while meeting the safety and efficacy requirements specific to each technology. The tables below provide examples of the devices evaluated.
| Codes | Devices |
| MDA 0306
Non-implantable active devices for extracorporeal circulation, administration or elimination of substances and hemapheresis
|
- Infusion pump, in combination with a drug. |
| MDA 0313
Non-implantable active prostheses, rehabilitation devices and patient positioning and transport devices
|
- Hospital beds - Patient lifts - Operating tables |
| MDA 0317
Non-implantable active devices for cleaning, disinfection and sterilization
|
- Steam sterilizers (small and large) |
| MDN 1101
Non-active cardiovascular, vascular and neurovascular implants
|
- Heart valve prostheses. - Nitinol self-expanding stents. |
| MDN 1102 Non-active osteo- and orthopaedic implants |
- Platelet-rich plasma/hyaluronic acid combination. - Artificial spinal disc - Spinal cage. - Spinal implant assemblies in a vertebrectomy model - Spinal arthrodesis implants. - Devices used for surgical fixation of the spinal skeletal system. - Total knee prosthesis - Total hip prosthesis - Ankle implants. - Bone cement. - Orthopedic screws and plates. |
| MDN 1103 Non-active dental implants and materials |
- Dental implants and abutments. |
| MDN 1104 Soft tissue and other non-active implants |
- Implantable catheter chambers. - Reconstruction implants (breast, gluteal). - Wall reinforcement and repair implants (abdominal, vaginal). - Contraceptive intrauterine devices. |
| MDN 1201
Non-active, non-implantable devices for anesthesia, emergency and intensive care
|
- Gas administration tubes. - Endotracheal tubes and endotracheal tube introducers. - Tracheostomy tubes. - Oropharyngeal airways. - Oropharyngeal cannulae. |
| MDN 1202
Non-implantable, non-active devices for administration, infusion and disposal of substances, including dialysis devices
|
- Thrombo-aspiration catheters. - Epidural catheters. - Infusion devices. - Blood sampling devices. - Transfusion devices. - Hypodermic syringes and needles. - Portable infusion devices. - Needle-based injection systems - NIS. |
| MDN 1203
Non-active non-implantable guide catheters, balloon catheters, guide wires, introducers, filters and related tools
|
- PTCA and PTA dilatation catheters. - Hemostatic valve. - Intravascular introducers, dilators and guidewires. - Central venous catheters. |
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