Remedus obtains certificate ISO 13485!
11 September 2017
Remedus has obtained the ISO 13485 ‘Medical devices – Quality management systems – Requirements for regulatory purposes’ certificate. That is an important step for a growing and innovating company that offers different services in the medical industry. The certificate applies to three different domains: software development for telemonitoring; offering services in home health care concerning patient monitoring, training and support; and finally, storage and distribution of sterile or non-sterile medical devices. That is a rather exceptional situation, since most companies are only active in one of those three domains.
From the start, Remedus has been active in patient training and the distribution of medical devices. Next to that, Remedus developed the product RemeCare, which is used as an online health-care coordination platform. The platform supports patients in their treatment at home and improves information access for health-care providers in primary, secondary and tertiary care. Thanks to the platform, the transition between those three runs seamlessly. For RemeCare, ISO 13487 is a leg up to the CE marking. The next big challenge for Remedus!