OSYPKA AG / Osypka Medtec Inc.

OSYPKA is a multinational medical device manufacturer with over 45 years of experience specializing in interventional cardiology and pediatric cardiology solutions. The company develops and manufactures active implants and catheters for cardiac applications, including pacemaker electrodes and radiofrequency ablation systems. OSYPKA operates as both a branded product manufacturer and a contract development and manufacturing organization (CDMO) serving global medical device partners with turnkey solutions for implantable devices and catheters. The company pioneered the first fracture-resistant implantable pacemaker electrode and has developed innovative technologies in cardiac intervention and neurostimulation. OSYPKA maintains manufacturing and quality capabilities across three main locations: Germany (headquarters in Rheinfelden), the USA (Longmont, Colorado), and the Czech Republic (Odry). The organization holds ISO 13485:2016 certification, EU Quality Management System certification under MDR (Medical Device Regulation), and Czech Quality Management System certification. The company serves interventional cardiologists, hospital systems, and medical device OEMs worldwide with both proprietary product lines and custom manufacturing solutions.