EU MDR (2017/745) Certification
Independent assessment services aligned with the EU Medical Device Regulation (EU) 2017/745 (MDR).
Certification Enquiry
Book a call to confirm scope, assessment steps, and next actions.
“Trust is earned through precision, and precision is proven by quality – every time, without shortcuts.”
About SIA DANEM MDC
Turning MDR Requirements Into Market Access.
SIA DANEM MDC is a dedicated subsidiary of the global holding Danem Test & Certificate, with a specialized team focused on medical device conformity assessment and certification activities aligned with the EU Medical Device Regulation (EU) 2017/745 (MDR). We work with manufacturers through a structured, project-specific process: from application intake and scope confirmation to technical documentation assessment and defined assessment steps. By agreeing on requirements, timelines, and deliverables upfront, we support audit-ready evidence, reduce rework, and keep MDR certification projects predictable.
MDR
(EU) 2017/745
All-in-One MDR Certification Services for EU Market Access
We provide independent certification and conformity assessment services aligned with the EU Medical Device Regulation (EU) 2017/745. Our process follows defined assessment stages: from application intake and scope confirmation to technical documentation assessment and agreed conformity assessment activities. By setting requirements, timelines, and deliverables upfront, we help ensure evidence is complete, consistent, and audit-ready while reducing rework and delays.
Contact
MDR Certification form
Submit your certification request
Our team is ready to discuss your MDR certification request and confirm the applicable assessment route for your device and intended EU market. Reach out using the contact details below, and we will respond promptly with the next steps.
