Cardiology & Cardiac Surgery

From diagnostics through interventional cardiology to open heart and thoracic surgery: this category brings together manufacturers of ECG and monitoring technology, catheter and stent systems, heart-lung machine accessories and the associated surgical instruments. On the supply side, what is chiefly required is fine wire processing, micro injection moulding, balloon and tubing extrusion and assembly under cleanroom conditions — processes with high demands on traceability and particle control. In regulatory terms much of this falls within Class III; documented process validation and experience with design dossiers are accordingly among the most important criteria when selecting partners.