Documentation Center

Access official product documentation, certifications, and technical files.

We provide controlled access to all official Roncadelle documentation to ensure compliance, traceability, and proper use of our medical devices.

Available documentation includes regulatory certifications, Instructions for Use (IFUs), and detailed technical specifications.

Access is granted upon request to ensure the correct and most up-to-date documents are provided.

Documentation Type

Access official certificates, IFUs, and technical documents.

Regulatory & Compliance

CE Certificates (MDR)

FDA 510(k) Clearance Documentation

ISO Certifications

Declaration of Conformity

Product Documentation

Instructions for Use (IFUs)

Product Brochures

Training Materials

Clinical Support Documents

White papers

Roncadelle White Paper (A4 – English)

Roncadelle Position Paper Booklet

Roncadelle White Paper NSI Booklet

Request Documentation Access

To ensure compliance with regulatory requirements, documentation is provided upon request. Please submit your email address and specify your request if needed.

All documentation is maintained under strict version control and complies with applicable regulatory requirements, including MDR and international standards.