Over the years, we have developed a robust manufacturing unit that designs and develops a diverse range of orthopedic devices. Our manufacturing unit encompasses the storage of raw materials, the design and development of products, and the quality control and packaging of products. As an exporter, we are committed to precision engineering, advanced materials, and strict quality control to ensure that our products are safe and effective for medical use.
We source high-quality raw materials, which is a critical part of our production process. Our products are sourced from reputed vendors and must meet stringent medical standards. Moreover, we efficiently manage supplies and inventory to ensure a steady supply of materials. We use the best quality biocompatible materials like titanium, stainless steel, and various polymers to ensure strength and compatibility with the human body. An essential step involves storing raw materials, as several of them are sensitive and require special care in accordance with ISO standards to guarantee their safety and hygiene.
We emphasize research and development and make use of the latest technology to develop new implants and improve existing designs. We utilize computer-aided design (CAD) software to design detailed 3D models of the implants.
We use the latest prototyping techniques and develop prototype models for testing and quality evaluation. These tests are mandatory for orthopedic implants to ensure that the final products are safe, effective and durable for mass production. Our various testing procedures include:
As a technology-driven company, we use the latest technology in our production process, including CNC machines for precise cutting, shaping, and drilling of metal components. Moreover, we are careful about surface treatment, using the best quality polishing, coating, and anodizing to improve the durability and biocompatibility of orthopaedic products.
We adhere to various regulatory compliances, including ISO 9001, ISO 13485:2016, CE, MDSAP and US FDA 510(k). We also maintain proper documentation with batch numbers, material certificates, and quality control reports. Another important point is our hygienic compliance. Our manufacturing design rooms are designed according to the norms of ISO 14644-1 under category Class 10000.
We maintain safe packaging norms where we maintain clean rooms and sterility. Before packaging, all our implants and devices are properly sterilized. These products are packaged and labeled as per EN 980 standards.
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