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MANUFACTURING TRAUMA DEVICES
Mikai has been in the medical device field for over 40 years producing and marketing products for traumatology, extremities and spinal specialties.
Mikai’s headquarters is in Genoa, Italy with a manufacturing facility in Vicenza where analysis, research and production of high quality orthopedic devices is performed, entirely made in Italy.
In the highly competitive orthopedic/traumatology market, Mikai has succeeded in breaking through with high quality products, certified to the strictest industry standards.
Over the years, Mikai has establish itself with: high quality products, a wide range of devices dedicated to TRAUMA, HAND, ORTHO, FOOT and DIABETIC FOOT, highly technical skills and attention to detail.
Mikai is involved in all phases of production. From 3D laser reproduction of project drawings designed in our technical office to CAD-CAM designs of the products sent to manufacturing, we work to analyze every detail and ensure the highest quality finished products.
THE PRODUCTION PROCESSFrom project to finish device
Laser scans
for 3D modeling.Laser scans
for 3D modeling.The bone or identified area is scanned to generate a 3D model to set the CAD/CAM parameters.
Machining products
from the technical design departmentMachining products
from the technical design departmentOur technical design department rolls out the final project for the manufacture of new orthopedic devices
Reverse engineering
digitalization of a productReverse engineering
digitalization of a productThanks to reverse engineering we can scan a product that and create 3D models which can then be used to reproduce a component or device.
CAD-CAM Processing
computer assisted design and manufacturingCAD-CAM Processing
computer assisted design and manufacturingWith the use of software for computer-aided design and manufacturing, information transfer is automated from the first to the second phase
Mechanical Processing
the production phasesMechanical Processing
the production phasesWe define the steps to take to produce a new surgical medical device, in accordance with the guidelines provided by the design
Machining Products
raw materials or semi-finished productsMachining Products
raw materials or semi-finished productsMikai also inspects the materials and/or components that will make up the finished product
Production Plant
the project turns into productProduction Plant
the project turns into productIt is here that ideas turn into medical devices manufactured by Mikai, through the effort of experts in the orthopedic/traumatology area and with the latest technology
Attention to detail
punctual and meticulousAttention to detail
punctual and meticulousMikai strives to ensure high-quality standards for its medical devices, assured by timely and scrupulous attention to detail
Quality
of the finished productQuality
of the finished productThe quality of the devices manufactured by Mikai is certified by UNI EN ISO 9001 and UNI EN ISO 13485
QualityWith Mikai quality is certified
ISO 13485 certification outlines in more detail the quality management system requirements that enable an organization to demonstrate its ability to provide medical devices and related services that abide by applicable regulatory requirements.
ISO 9001 quality certification certifies Mikai’s focus on procedures that ensure high quality standards and continuous improvement through customer feedback and addressing their needs.
All Mikai products are CE certified per Directive 93/42/CEE, as recently amended by Directive 2007/47/CE relating to active implantable medical devices and the authorization to commercialize a device within the European Union.
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Our customer service department will answer all your questions and advise you of the best solution for your needs
