Quality Management

Our management system complies with the requirements of UNI CEI EN ISO 13485:2016 and UNI EN ISO 9001:2015 standards and is valid for the design, production, and marketing of medical devices for orthopedics and traumatology.

CE Certificate

Episcan Srl holds CE certificates of approval for the Full Quality Assurance System. Italcert has verified this system in accordance with the applicable legislation, as per Annex II (excluding section 4) of Directive 93/42/EEC on Medical Devices.

The certified devices belonging to the Episurgical, Episurgical Micro, and Epifix product lines include: screws, plates, nails, staples, wires, drills for traumatology, and external fixators.