Above-knee mechanical prosthetic legs

We manufacture all implants on Sliding head CNC machines. Dimensional calibration of every cutting tool is done on a daily basis, if not proper we change the cutting tool. Apart from that machine software calibration & moving part calibration is done on a monthly basis. The purpose is to provide you with dimensionally accurate Implants. We have 3 class 10000 Clean rooms & 1 class 100 area, each clean room has a separate air handling unit with 2 pre-filters of 5 microns and 0.3 microns HEPA filters. Clean room validation is done quarterly and includes a HEPA filter Integrity test, Air velocity test, differential pressure test, particle count and environment monitoring test by microbiological method. We follow GMP standards. The aim is to provide bioburden & foreign particle-free sterile products.

No human interface or error in QC and it is done by a computerized Coordinate Measuring machine. It is to measure the profile, geometry & dimensional of the final product. Assured Quality We follow ASTM & ISO testing standards for batch release. There are in total 22 types of mechanical, biological & chemical tests. By doing this we can assure the quality of the product and if any medico-legal condition will be arise then we can protect ourselves & dental surgeon by documented evidence.

We follow 100 sops, 74 documented checkpoints and 22 tests to manufacture a single batch. 1. SOP indicates how to perform some tasks correctly. So humans can perform a task correctly without any confusion or human error. We follow more than 100 sops. 2. As per Good manufacturing practice guidelines, there are 74 files in which we record our all activities, which is required for Traceability.

Clinical follow-up is required to prove the safety and efficiency of the product. We have adopted best-skilled practices in the industry and consistently improve ourselves. If you are looking for the best clinical results then our product is definitely for you.