Regulatory Affairs

The management and employees of CapeRay are committed to provide world class quality products and services, at an economic cost, that will fully satisfy customer requirements.

The policy of CapeRay in achieving its quality objectives is to utilise an effective Quality Management System specifically designed to recognise, control and monitor all processes that enable, influence and ensure the quality of the products and services.

CapeRay is also committed to comply with all applicable legal (statutory and regulatory) requirements in all applicable jurisdictions.

This quality system is certified to be in compliance with ISO 13485:2016 requirements and must be understood, implemented and maintained by all employees throughout the organisation. CapeRay’s ISO 13485 certificate is seen below. You can click on the image to open the certificate in full size in a new tab. In setting up our Quality Management System we have followed the eight Principles of Quality Management, which align with the ISO 13485 requirements:

  1. Customer Focused Organisation
  2. Leadership
  3. Involvement of People
  4. Process Approach
  5. System Approach to Management
  6. Continual Improvement
  7. Factual Approach to Decision Making
  8. Mutually Beneficial Supplier Relationships

Aceso has not yet been submitted to, or cleared by, the Food and Drug Administration (FDA) in the USA.