Manufacturing

Mikai ENCompanyManufacturing

MANUFACTURING

Mikai has been the orthopedics-traumatology market for almost 40 years producing and selling products for trauma and bone and joint synthesis/correction.

Mikai’s headquarters is in Genoa, Italy with its manufacturing facility in Vicenza where analysis, research and production of high quality surgical medical devices is performed, entirely made in Italy.

In the highly competitive orthopedics-traumatology market, Mikai has succeeded in breaking through with high quality products, certified to the strictest industry standards.

Today Mikai is considered a leading orthopedics-traumatology company thanks to excellent quality products, a wide array of devices dedicated to TRAUMA, HAND, ORTHO, SPINE and FOOT, high technical skills and attention to detail.

Mikai is present and active in all phases of production. From laser scanning for 3D reproduction of project drawings from the design team to CAD-CAM designs of a product to the manufacturing process ending in the machining workshop, where man and technology work to observe every single detail and ensure the highest quality finished product.

THE MANUFACTURING PROCESSFrom Concept to Product

Laser Scanning

for 3D reproduction

Laser Scanning

for 3D reproduction

We perform a laser scan of the bone, or affected area, for subsequent 3D reproduction and CAD-CAM processing

Internal Designs

from the Technical Design Department

Internal Designs

from the Technical Design Department

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

Reverse engineering

Digitalization of a Product

Reverse engineering

Digitalization of a Product

Thanks to reverse engineering we can scan a product that has no CAD description and create 3D models which can then be used to reproduce a component or object

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 is also involved in the production of all 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 orthopedics-traumatology sector and the latest machinery

Attention to detail

punctual and meticulous

Attention to detail

punctual and meticulous

Mikai works 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 surgical medical devices manufactured by Mikai is certified by CE 2007/47, UNI EN ISO 9001, UNI EN ISO 13485.

QualityWith Mikai quality is certified

ISO 9001 quality certification confirms Mikai’s focus on activities to formalize procedures that ensure high quality standards and continuous improvement, by collecting the customer’s suggestions and addressing their needs

Download the Certificate

ISO 13485 certification specifies more in detail the quality management systems requirements that enable an organization to demonstrate its ability to provide medical devices and related services that meet the customers’ and applicable regulatory requirements

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 possibility to commercialize the 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