ISO 13485

13 December 2016

Manufacturers are only allowed to sell medical devices with a CE marking. This has been written down in European directives concerning medical devices, which describe the quality requirements for manufacturers of medical devices. The EN-ISO 13485 norm is a harmonized norm which specifies the requirements for a quality system with regard to medical devices.

In September 2017, Remedus obtained the ISO 13485 certificate. This certificate applies to three different domains:

  • To develop telemonitoring software
  • To offer home health-care services concerning patient monitoring, training and support
  • To store and distribute sterile or non-sterile medical devices

That is a rather unique situation, since most companies are usually only active in one of those three domains.

To obtain this certificate, Remedus carried out several audits of its entire quality system. The certificate stays valid for three years. Each year, an inspection will be held to check if we still meet the norm’s requirement and our own quality management system’s requirements. Every three years, a recertification will take place.

In February 2018, the RemeCare software was also rewarded with a CE marking. CE stands for conformité européenne, which means ‘in accordance with European directives’. The CE marking demonstrates that the RemeCare software complies with all European regulations, the conformity assessment procedures are completed and a declaration of conformity has been drawn up.

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