Certifications

Commitment to Quality, Health and Safety

Certifications

At Copenhagen Imaging, we are fully committed to upholding the highest standards in Quality, Health and Safety.

As part of this commitment, we have implemented a robust quality management system in compliance with ISO 13485, a globally recognized standard for medical device quality management.

We are transparent about our certifications and invite you to review them. Please find the links to our certifications on SharePoint below:

We continually review and improve our processes to ensure we deliver safe and effective products, maintain a healthy and safe workplace.

If you have any questions or would like further information about our commitment and certifications, please feel free to contact us.

Notified Body Update

Copenhagen Imaging ApS has designated SGS Fimko (NB 0598) as its Notified Body responsible for certification and surveillance of current and future medical device products from Copenhagen Imaging under the EU Medical Device Regulation (MDR 2017/745).