Certifications & Compliance
Pelement Medical is committed to the highest standards of quality and safety. All medical devices are designed and manufactured under an ISO 13485 quality management system and are CE marked in compliance with the EU Medical Device Regulation (MDR) 2017/745.
ISO 13485
Quality management system for the design and manufacture of medical devices.
ISO 13485 certificate image — to be uploaded
CE (EU-MDR)
CE marking in compliance with EU Medical Device Regulation (MDR) 2017/745.
CE certificate image — to be uploaded