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 recognize, 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 system is compliant with ISO 13485:2008 requirements and must be understood, implemented and maintained by all employees throughout the organisation. 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

In June 2012, CapeRay received the following ISO certifications, as well as the CE mark for the Pandia digital x-ray camera. Regulations currently dictate that we can no longer CE mark components of medical devices as medical devices themselves.

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Note that CapeRay’s dual-modality Aceso system does not yet have either the CE Mark or FDA Approval and is therefore regarded as an investigational device.