Recently IBI SA got the CE in the ortho field by the certifying body BSI, a long-awaited milestone achieved with the cooperation of the whole company. In order to celebrate it, we go back to the important steps that characterized this journey in the orthopaedic sector. Thus, this monthly interview is focused on our Quality and Regulatory Affairs Manager.
Hi folsk! I’m Luisa and I grow up in Pescara, but now I’m living in Lugano.
I’m a Biomedical Engineer and I completed the Master Degree at the Politecnico of Turin.
I’ve been working in IBI as Quality and Regulatory Affairs Manager since last September, but I’ve known the Company for 5 years.
My main task is to ensure that each process has to be in compliance with the relevant regulatory laws of different countries, and that the company’s products meet the quality standards.
This kind of role requires high responsibility and the ability to be collaborated with all the company’s department to be sure for obtaining always safe and high quality products.
It’s a big challenge!
Yes, finally we got it and I feel very satisfied!
It is a great goal for IBI for many reasons. In the past, IBI already had the orthopedics application in the CE certificate, but the previous Notified Body lost the notification and the Company had to start a new certification process.
Moreover, the regulatory framework which the medical device field is going to be change, and (fortunately!) requires increasingly restrictive controls to have safer and more effective products. To get the certificate in this scenario means that IBI has been awarded for its efforts!
When I joined the Company, my first task was to manage the requests received from the NB about Ortho certification. Therefore, the big challenge for me was to understand wholly SmartBone® as soon as possible for getting able to interact with the NB.
For example I had to face on with the production and the sterilization process, the chemical and physical characteristics of the product, and the clinical information.
Fortunately, I’ve already knew many of this topics during my university itinerary and thanks to my previous work experiences, I was able to handle all this matters.
Anyway, the process for getting the CE mark was not very difficult but mainly very long, as per all kind of these applications.
It’s correct, infact as I told you before, IBI has introduced its bone grafts into the market in 2012 which was intended to be used in bone regeneration applications and around 2015, IBI has started to work in the orthopedic fields.
SmartBone® was deeply investigated and completely characterized from a biomechanical profile, since for orthopedic application, the mechanical properties for a bone grafts are very important.
Moreover, we started an observational study to collect clinical data obtained from patients who underwent reconstructive surgeries (from either trauma, or orthopaedic or oncology) in 2015.
SmartBone® ORTHO can be used in three different area: for orthopedic reconstructive surgeries, in traumatology and oncology.
In traumatology it can be used in cases of the traumatic trabecular bone loss, which is caused by both high-energy impacts and traumas in osteopenic patients, which both result in loss of trabecular structural architecture.
In oncology, it can be used in orthopedic reconstructions after tumor surgery, as in curettage or after en bloc resections.
Last but not least, the Ortho CE Certificate allows us to extend the custom made process from dental to orthopedic application!
It was my pleasure to share with you my experience!