ISO13485 Medical Devices

ISO 13485 specifies requirements for a Quality Management System for organisations looking to enter the medical device supply chain. The focus of ISO 13485 is to ensure design and manufacturing processes consistently produce quality products that meet regulatory requirements.

As with all ISO certification standards, it is internationally recognised and provides numerous benefits including:

  • Increased credibility in your organisaton's competence and profile
  • Ability to enter the medical device supply chain, and supply to larger organisations who require their suppliers to be certified
  • Increased traceability of material snad operations through your processes
  • Improved organisation and housekeeping through your premises

ISO13485 is based on the foundation of ISO9001 so any organisation that already is ISO9001 certified has already gone a long way towards meeting the requirements ISO13485.

Contact us today for more information on ISO13485 and how we can help you achieve certification.