Our Manufacturing Standards

 

Licences and Certifications

We follow Good Manufacturing Practice (GMP) principles and hold:

  • EN/ISO 9001:2015 – Quality Management Systems - Requirements

  • ISO13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes

  • APVMA Licence

We are fully engaged in continuous improvement to optimise systems and procedures to be able to address the ever-changing regulatory requirements and meet our customer needs.