Manufacturing
Stable manufacturing processes are the foundation for ceramic implants conforming with specifications.
Based on more than three decades of experience regarding powder processing, thermal treatment and finishing HiPer Medical fulfills this requirement.
Advanced production technologies warrant reliable mass production of ELEC®- and ELEC®plus implants.
High-level automation, specially tailored powder processing and machining technologies as well as appropriate cleanroom environments ensure reproducible component quality and therefore patient safety.
Quality Assurance
Continuous monitoring of all manufacturing steps as well as comprehensive approval testing of every single component assure a maximum of product safety.
The outstanding biocompatibility of ELEC® and ELEC®plus implants has been - beyond obligatory testing - validated in long-term human cell and tissue culture and is completely confirmed in ten years of clinical use.
Our certified Quality Management System complies with ISO 13485 and regulatory standards. ELEC® and ELEC®plus implants are available as certified final products – sterilized, packed - or OEM-components.
Certificates
EC-Design Examination Certificate
QS-Certificate EN ISO 13485:2012 + AC:2012
