At TOV Implant, we place paramount importance on the quality and compliance of our products with the most rigorous standards and certifications. Our dental implants undergo thorough technical and quality control processes to ensure their optimal performance.
Each TOV Implant product is identified by a unique lot number, and all our raw materials are meticulously inspected upon arrival at our manufacturing facility. Furthermore, we implement strict quality controls at every stage of production to ensure the reliability and quality of our implants.
The sterilization of our products is carried out according to very strict standards, including exposure to gamma rays at an intensity of 2.25 m.rad. This procedure meets the most rigorous requirements of European health laws and directives regarding patient health and safety.
We fully comply with the essential requirements established in European laws and directives related to health, ensuring our products deliver optimal performance and maximum safety for patients.
Our quality management system is process-oriented, with quality assurance focused on the future. We ensure the long-term consistency and durability of our products through rigorous testing conducted in our own facilities, with our own equipment.
TOV Implant is proud to be certified according to Directive 93/42/EEC on medical devices, Annex II, excluding section 4, by Notified Body CE0482, Medcert. This certification demonstrates our commitment to excellence and our dedication to providing superior-quality products to our customers worldwide.
Additionally, we are actively engaged in the transition to the new Medical Device Regulation (MDR) directives for our CE standards, thereby demonstrating our ongoing commitment to improvement and adaptation to evolving regulatory requirements.
Regarding our FDA 510(k) standards, we work closely with competent authorities to ensure compliance of our products with the strictest standards of safety and efficacy in the United States. This approach reinforces our commitment to product quality and safety for our customers worldwide.
