Quality Control/Quality Assurance

Since we are dealing with invasive medical products, quality is our number one priority. Our work complies to the ISO 13485:2016 and our Patient Specific Implant protocol.

All implants and other products traceability are maintained throughout production.

Primary and secondary packing has been used as per regulatory requirements.

Whenever required polymer-based bio-model is used for checking implant fitting.

We have conducted validation/calibration of required equipment, instruments.

Along with implant, we manufacture a plate (control sample) in same batch. Control sample will be passed through all process. And kept in control sample room for identification and traceability.

If something fails in the future, we can test this control sample for chemical analysis, etc.

ISO 900:2015 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.

Testing and validation