Aalborg, Denmark — 28 January 2026. NOVO Imaging has received recertification to ISO 13485:2016 following a successful surveillance audit conducted by an accredited third-party certification body. The certification covers NOVO Imaging’s quality management system for the trading, refurbishment, storage, and after-sales servicing of medical imaging equipment and spare parts.
ISO 13485 is the international standard for quality management systems in the medical device industry. Compliance demonstrates that NOVO Imaging operates systematic processes for device traceability, customer complaint management, risk assessment, and continual improvement — aligned with the requirements of the EU Medical Device Regulation (MDR 2017/745).
“Maintaining ISO 13485 certification is not just a compliance requirement for us — it directly supports the confidence our clients place in the equipment and parts we supply,” said Michael Andersen, CEO. “The audit found zero non-conformities, which reflects the commitment of the whole team to quality operations.”
The recertification extends NOVO Imaging’s certification status through January 2029. Documentation is available on request for procurement and compliance purposes.