Production
Controlled processes for global scale
Controlled production processes are the foundation for manufacturing ceramic implants that meet strict specifications. At HiPer Medical, we build on more than 30 years of experience in powder preparation, thermal processing, and precision finishing to meet these demanding requirements.
Our state-of-the-art manufacturing methods enable the reliable production of large quantities of ELEC® and ELEC®plus implants while maintaining exceptional quality standards. The combination of advanced automation, customized process solutions, and cleanroom environments ensures consistent product quality. This reliability is crucial for guaranteeing the safety and performance of components used in medical applications.
By integrating innovation with proven expertise, HiPer Medical provides high-performance ceramic components that set new benchmarks for durability and precision in the field of implant technology.
Quality Assurance
Ensuring the safety and quality of our products is our top priority. We achieve this through continuous monitoring of all manufacturing stages, combined with rigorous final inspections of each individual component. These measures ensure that every implant leaving our facilities meets the highest safety and performance standards.
The exceptional biocompatibility of ELEC® and ELEC®plus implants has been validated through extensive research and testing. Beyond mandatory investigations, we have conducted long-term studies in human cell and tissue cultures, confirming their compatibility and safety. Over a decade of successful clinical use further demonstrates the reliability and effectiveness of our materials.
HiPer Medical operates under a certified quality management system in compliance with ISO 13485. This certification reflects our commitment to producing medical devices of the highest standard. We offer ELEC® and ELEC®plus implants as fully certified proprietary products or as OEM components, tailored to the specific needs of our partners.
Certificates
HiPer Medical’s adherence to international quality standards is validated by our ISO 13485 certification. This accreditation ensures that all aspects of our design, production, and quality assurance processes meet the stringent requirements necessary for the manufacturing of medical devices.