Sg Medical

SG Medical is a medical device contract manufacturer that specializes in the highest-Class risk (Class MDR 2017/745) medical devices. We develop and manufacture catheters and other medical devices with focus on electrophysiology, interventional cardiology, neurovascular applications. We offer our clients a wide range of manufacturing capabilities, from early design stage, prototyping, verification to full scale production. Key medical device technologies offered by SG Medical include Catheter assembly, shaft reflow, UV/IR Gluing, Soldering, Shaft Wire embedding, sensors integration and optical connectorization All our manufacturing services are ISO 13485:2016 certified with State-of-the-Art manufacturing equipment and machinery, and a dedicated workforce for catheter processing and catheter testing. ENGINEERING: Micro-Assembly Catheter labs fully equipped, Design, Process Development, Prototyping MANUFACTURING : ISO 7/8 Clearooms, Pilot Line, Scale UP, Volume Manufacturing VALIDATION : Verification and Validation Compliant to – Manufacturing Validation: IQ, OQ, PQ, PPQ TMV QUALITY: Certified ISO13485 for Class Medical devices, Final, Incoming and In-Process QA Inspection