Saline Lectronics, Inc., a leading electronic contract manufacturer, today announced that its Saline, MI facility is now cGMP compliant and registered by the Food and Drug Administration (FDA). These certifications, along with Saline’s current ISO 13485 standard, demonstrate the company’s ongoing dedication to providing high-quality circuit board assemblies for medical applications.
As a full service CM serving the medical market, Saline Lectronics has many customers that require strict quality codes that follow FDA-Good Manufacturing Practice (cGMP) standards defined by the FDA 21 CFR (Code of Federal Regulations) Part 820 QSR (Quality System Regulation). To qualify for this QSR, Saline demonstrated its ability to implement a quality system for designing, manufacturing, packaging, labeling, stocking and delivering medical devices sold within the United States.
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).
“Our involvement with the medical industry has greatly expanded over the last couple of years. We have made a commitment to the medical field, and now that we are certified to the new quality and manufacturing standards as required by the FDA, we offer an added value service to both our current and future customers,” commented Mario Sciberras, President of Saline Lectronics.
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.