Certifications

TÜV SÜD: EU Quality Management System Certificate (MDR), pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX

TÜV SÜD: DIN EN ISO 13485 (Quality Management System for Medical Devices)

DGP GmbH: Pre-Qualification acc. § 126 SGB V (German Law - Qualified Supplier of Durable Medical Equipment)

U.S. Food and Drug Administration: 510(k) Premarket Notification for Saalio/The Fischer