Nov 19, 2012 Saline Lectronics, Inc., a leading electronic contract manufacturer, today announced that its Saline, MI facility has received its recertification to the ISO 13485 standard. This recertification, along with Saline’s current cGMP compliance and Food and Drug Administration (FDA) registration, demonstrates the company’s ongoing dedication to providing high-quality circuit board assemblies for medical applications.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
As a full-service CM serving the medical market, Saline Lectronics has many customers that require strict quality codes. To attain its recertification to the ISO 13485:2003 standard, Saline demonstrated its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services.
“This recertification represents our ongoing commitment to quality for medical applications. Over the last 10 years we have built a reputation for superior service, available inventory and versatility in responding to the most challenging requirements. We hold ourselves to the same high standard for the medical industry,” commented Mario Sciberras, President of Saline Lectronics.
Saline Lectronics is a leader in its industry for manufacturing medical circuit board and box build assemblies. The company serves low- to mid-volume manufacturers of a wide variety of medical fields including biomedical, cardiovascular, wound care, lasik technology and portable imaging equipment, to name a few. Some of Saline’s services include contract design supporting DFX for manufacturing, assembly of manufacturing technologies, circuit board testing and final product assembly to the pack-out level (box builds).
Saline Lectronics provides the latest manufacturing expertise including THT, SMT, BGA, microBGA and different bottom-terminated component capabilities, as well as other challenging mixed-technology assemblies. For more information about Saline Lectronics’ capabilities, visit www.lectronics.net.
