Consulting and Assistance in Quality and Regulatory Affairs in the field of medical devices
Med'In QARA
My name is Stéphanie Garbez and I'm the founder of Med'In QARA, a consulting firm dedicated to medical device manufacturers, whose mission is to ensure that quality, compliance and safety are at the heart of every project.
In 25 years, I've had the opportunity to work as Lead Auditor for a Notified Body, and Technical Manager for a National Testing Laboratory, for which I obtained two COFRAC accreditations. I have also held positions of responsibility within international groups, such as Design Quality and Test Laboratory Manager, or Global Quality and Regulatory Affairs Director. All this experience has enabled me to develop in-depth expertise in medical device assessment, quality system and technical documentation audits, quality system management and the drafting and review of technical documentation.
My technical background (Materials Engineer, coupled with a Master's degree in Biological and Medical Engineering), combined with my years in the laboratory, enable me to understand the technical constraints associated with devices. With Med'In QARA, I can offer in-depth expertise and support combining quality, regulatory and technical expertise to meet the specific needs of medical device design and development, and process validation.
My threefold skills guarantee my customers pragmatic support in the service of innovation and technology, while integrating quality and regulations into their projects in a way that is sustainable over time.
I'm also convinced that quality and regulation are levers for a company's development , so I place great importance on human support, working closely with each company to meet its specific needs and strategy.
Finally, to keep abreast of developments in standards and practices, I invest actively in continuing education. I belong to networks of auditors, assessors and consultants in the sector, and have forged stimulating and complementary partnerships. As a result, Med'In QARA offers comprehensive and constantly updated support, both in Europe and internationally.
Med'In QARA embodies my values: rigour, listening, ethics and commitment to the safety and performance of medical devices.
Intervention zones
Med'In QARA can operate both in France and internationally, whether you're located in Europe, the USA, Asia... This international reach means that we can meet customers' needs in different markets, and adapt strategies to suit local requirements.
Medical devices assessed
Throughout my career, I've had the opportunity to work on a wide variety and class of medical devices: from medical beds to orthopedic implants, from coronary dilatation catheters to perfusion devices. These experiences have enabled me to develop comprehensive expertise in devices from Class I to III, integrating the safety and performance requirements specific to each technology. The table below gives examples of the devices I have worked on:
| Codes | Devices |
| MDA 0306
Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
|
- Infusion pump, in combination with a drug. |
| MDA 0313
Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
|
- Hospital beds - Patient lifts - Operating tables |
| MDA 0317
Active non-implantable devices for cleaning, disinfection and sterilisation
|
- 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 dental materials |
- Dental implants and abutments. |
| MDN 1104 Non-active soft tissue and other implants |
- Subcutanéous implanted ports. - Reconstruction implants (breast, gluteal). - Wall reinforcement and repair implants (abdominal, vaginal). - Contraceptive intrauterine devices. |
| MDN 1201
Non-active non-implantable devices for anaesthesia, emergency and intensive care
|
- Gas administration tubes. - Endotracheal tubes and endotracheal tube introducers. - Tracheostomy tubes. - Oropharyngeal airways. - Oropharyngeal cannulae. |
| MDN 1202
Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
|
- 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, guidewires, introducers, filters and related tools
|
- PTCA and PTA dilatation catheters. - Hemostatic valve. - Intravascular introducers, dilators and guidewires. - Central venous catheters. |
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