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Manufacturing

Mikai ENCompanyManufacturing

MANUFACTURING

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 department

Machining products

from the technical design department

Our technical design department rolls out the final project for the manufacture of new orthopedic devices

Reverse engineering

digitalization of a product

Reverse engineering

digitalization of a product

Thanks 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 manufacturing

CAD-CAM Processing

computer assisted design and manufacturing

With 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 phases

Mechanical Processing

the production phases

We 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 products

Machining Products

raw materials or semi-finished products

Mikai also inspects the materials and/or components that will make up the finished product

Production Plant

the project turns into product

Production Plant

the project turns into product

It 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 meticulous

Attention to detail

punctual and meticulous

Mikai strives to ensure high-quality standards for its medical devices, assured by timely and scrupulous attention to detail

Quality

of the finished product

Quality

of the finished product

The 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.

Download the certificate

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.

Download the certificate

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.

Download the certificate

Do you want to know more about the products and services offered by Mikai?

Our customer service department will answer all your questions and advise you of the best solution for your needs