Kinetical S.R.L. was born in 2003, as a branch of another company dedicated for over 50 years to the metalworking industry, with the purpose of entering the national market with technological developments in the biomedical sector.
We are mainly dedicated to the design development, manufacture and commercialization of implantable medical devices. Our production portfolio is divided into five lines: spine, titanium trauma plates, dental, arthroscopy and customized implants for cranial reconstruction.
Our company is certified by the national regulatory agency (A.N.M.A.T. File 1628) and complies both with the Good Manufacture Practice (GMP) and with the highest quality standards required by the regional and international markets. We have highly trained personnel who guarantee a quick response to our customers´ needs, price competitiveness and a great capacity to investigate and develop innovative proposals.
Supported by constant technology and investment contributions, Kinetical has experienced a substantial growth over the past years. We have enlarged the size of our facilities, acquired state-of- the-art technology and incorporated skilled personnel. All this has enabled us gain prestige within the local market.
Design
We have a group of trained professionals specifically dedicated to the task of interpreting our customers´ needs and turning them into sample prototypes using CAD software based on a drawing or through the application of inverse engineering. The end prototypes can be tested with mechanical trials in laboratories of recognized national universities.
Production
We combine state-of- the-art technology, risk management, process validations and highly trained personnel to obtain high quality products that seek safety, efficiency and precision.
Quality control
Our group of professionals is responsible for the maintenance of a rigorous quality system that performs a double control, dimensional and of processes, (in the machine and prior to packaging) using calibers, profile projectors and microscopes. Moreover, as required by the Good Manufacture Practice norm, all our products are completely traceable.
Cleanroom
We have an ISO Class 7 cleanroom where the ultrasound cleaning, packaging and preparation processes are performed. Our products can be packaged to be commercialized non-sterile or they can be sent forsterilization by any of the well-known methods.
Technologies
Machining:
-CNC- lathe
-5-Axis Machining Centre
-EDM wire-cutting machine
– Multi-spindle lathe
Secondary Operations:
-Laser marking
– Anodizing-color and type II codification
– Blasting
– Polishing-rotofinish
– Pickling and chemical passivation