US-based Vishay Intertechnology's Tantalum Capacitors Division has secured the International Organization for Standardization (ISO) 13485:2003 certification for its facility in Dimona, Israel.
Vishay’s ISO 13485:2003 registration audit was conducted by the Standards Institution of Israel (SII), following which the site was certified for the design and manufacture of tantalum capacitors for the medical market.
The company’s Dimona plant manufactures tantalum capacitors for implantable life support equipment, such as pacemakers and ICDs, as well as neurostimulation devices.
By producing these components to the stringent standards required by ISO 13485:2003, Vishay noted that it continues to demonstrate its commitment to the medical industry.
ISO 13485:2003 certification specifies processes for a company’s quality management system to show its ability to provide medical devices and related services that meet regulatory and customer requirements pertaining to medical device application standards.