Axio products are manufactured in ISO 13485:2016 certified facility owned and operated by Axio.
- State of the art manufacturing facility is located in Pharma tech park at City of Ahmedabad, Gujarat, India.
- Custom built imported machinery with 75-80% automated processing. Minimal human intervention reducing handling errors.
- 5000sq.ft cleanroom area built according to cGMP, FDA guidelines under Class 10000 manufacturing area.
- Gamma sterilization done terminally. · Full traceability from finished product to raw material source.
- All 3rd party vendors audited and qualified by EU notifying body.
Axio is an equal opportunity employer with commitment to equal treatment of all employees without regard to race, origin, religion, gender, age, sexual orientation, physical or mental disability or other basis protected by law.
Axio ensures and complies with environmental policies for manufacturing facility of medical devices. No hazardous, polluting effluents are discharged into the environment. Proper handling and disposal of industrial waste is in compliance with local law.
We at Axio benchmark ourselves to global standards and follow appropriate regulatory guidelines in respective countries of operation. We follow a process that is based on a strong foundation of manufacturing quality standards, mutually beneficial relations with our customers, dealers and all professionals associated with us.
- Audited and certified by European Notifying Body – Det Norske Veritas (DNV), Norway.
- Dedicated In-house Quality R&D with specialized equipments for testing.
- Expert QA and QC team who has undergone rigorous ISO 13485:2016 internal auditor training programs