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OSYPKA AG – your OEM partner for First & Second Generation Products & Innovations
OSYPKA achieved CE mark according to MDR
We are proud to announce that the OSYPKA AG has received the first CE mark according to the new Medical Device Regulation (MDR) for a Class III product in the field of Cardiac Pacing/CRM. "This is a new milestone that is also valuable for our OEM customers, as we cover all processes, from design idea to patient application according to the highest standards," says CEO Nicola Osypka. Since 1977, OSYPKA AG has been developing, manufacturing and bringing to market class III medical devices. OSYPKA offers turn-key services including regulatory approval also to contract customers world-wide.