To help achieve this we are committed to continually improving our ISO13485 Medical Devices Quality Management System to exceed both customer expectations and the company’s quality objectives.

Our systems and procedures are regularly evaluated through internal audits, customer audits and through BSI. This helps ensure we have the most stringent controls in place to deliver top quality products.We have also invested in an experienced team and state of the art inspection equipment to comply with our customers’ requirements and our own quality assurance system.


Our Quality objectives are simple: ensure compliance with all applicable Regulatory Standards while implementing customized validation and quality assurance systems that meet each of our customers’ specific requirements.

The Team at Cambus Medical can assist with the Quality and Regulatory requirements for products and projects, including:


  • ISO 13485 Certification
  • Risk Management
  • First Article Inspection
  • Test Method Development
  • Statistical Sampling
  • Gauge R&R
  • Product and Process Validations
  • Process Capability Studies
  • ISO 14001 Certification

BSI Cert of Reg 2020 CI

14001 Environmental Management Certificate BR