Compliance

Our system meets the highest performance, quality, and safety (PQS) standards as specified by the World Health Organization and is one of only four systems in the world to hold such certification.

Why is the World Health Organization Performance-Quality-Safety (WHO - PQS) certification important?

The PQS approach to equipment and device prequalification is based on three key criteria:

• Performance – The device must meet the performance characteristics / functionality as stipulated in the PQS-E006 specification for remote temperature monitoring devices;
• Quality – Places a key focus on the accuracy and reliability of the device appropriate for field conditions considering things like reliability and quality of power supply, availability and reliability of ICT infrastructure, etc;
• Safety – Cradle-to-grave safety characteristics that ensure no harm is caused to users or patients over the course of the product’s life cycle. This includes extensive lab tests conducted to measure the electromagnetic radiation of the device to ensure that it does not in any way interfere with other sensitive equipment which may be nearby. This is particularly relevant in a hospital / clinic / laboratory environment.

On an ongoing basis the WHO monitors each device in the market to assess performance, quality and safety characteristics over its life cycle from the perspective of the user and patient. They also gather end-user feedback to ensure ongoing sustainability and suitability for programmatic and operational needs.

All devices are subject to a formal annual review process to ensure that the standards are properly maintained. This takes place in April each year.

In short, the WHO PQS certificate is more than just a piece of paper! It is a written assurance from the highest authority in global healthcare that the product you are using is up to the task of reliably, accurately and safely monitoring your cold chain, to ensure that your medication is able to effectively prevent and manage disease.

DOWNLOAD CERTIFICATES

WHO Performance-Quality-Safety Certificate
ISO 9001 Certificate
ISO/IEC 27001:2013 Certificate
ISO/IEC 27001:2022 Certificate