While applying disruptive technologies, Quality is the base of Element 22s manufacturing processes.
Throughout the organization, all Element22 employees are responsible for Quality. Element22’s foundation is the company culture, regulatory compliance and pursuit of best technology & production methods available to serve our customers’ needs.
Element22 has implemented quality objectives that are periodically updated in order to bring the best products and services to the market by:
Element22 GmbH has a certified quality management system according to the international standards EN/ AS 9100, EN ISO 13485 and ISO 9001. Our certificates can be downloaded below:
The implantable Titanium MIM components are approved around the globe for implantation into the human body. These parts are manufactured and certified according to the following ASTM standards:
In addition, our Ti MIM material has been tested for biocompatibility, toxicity, geometric repeatability, mechanical and chemical material characteristics, surface finish, density, microstructure, fatigue life, stress corrosion cracking, weldability and more.
Our Ti Powder Metallurgy manufacturing processes are proven with validated equipment and processes for the medical industry.
The first Titanium MIM parts had approval to implant in Europe Asia and South America in 2006. In 2012 the first Titanium MIM parts made by Element22 received FDA approval to implant in USA.