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Promex, located in Silicon Valley, is an ISO 13485:2003 Medical and ISO 9001:2008 certified microelectronics, semiconductor & advanced packaging and high reliability SMT/PCBA contract assembly service provider for the medical & bioscience, commercial and military markets. Core competencies allow the sequential steps of prototypes, new product introductions & beta production, followed by volume manufacturing. Complete in-house microelectronics process capabilities and process expertise uniquely integrates SMT / PCBA with microelectronics assembly. Facilities include Class 100 and Class 1000 clean rooms, RoHS optimized SMT/PCBA lines, plus development & assembly areas. ISO 13485 Medical process verification and validation using IQ, OQ, PQ and pFMEA practices and extensive use of statistical process controls. Complete Microelectronics Assembly Process Flows: • Wafer handling and sawing including 300 mm wafers • Fully automatic die attach • Wire bonding (Au ball, Al wedge, RF ribbon & wedge, Cu) • Plastic over molding (multi-chip modules, arrays, system-in-package) • Precision materials dispense • Encapsulation • Flip Chip High Reliability SMT/PCBA and Chip-on-Substrate: RoHS optimized SMT lines allow single facility process integration. Leaded solder processing also available. Chip-on-Substrate expertise. IPC-A-610 Class 3 assembly. Consigned and full turnkey SMT/PCBA and supply chain management. Quality Systems (Medical): FDA Title 21 Part 820 compliance ensures device history files, operator training records, IQ, OQ, PQ and process documentation meet all standards.
CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF).
MedVenture Technology dedicates resources to building a strong community. Employees passionate about a charitable organization are encouraged to share their enthusiasm at work. Volunteers are recruited, donations are accepted, and families all around us
Hancock Jaffe Laboratories, Inc. is a medical device company based out of Irvine, California, United States.
MY01 is a state-of-the-art medical device geared towards aiding in the detection of Compartment Syndrome (CS); a limb-threatening muscle condition that occurs within 48 hours following trauma. Currently, ACS is diagnosed based on subjective and unreliable outcomes like pain (known as 6 P`s), which when present cannot confirm the diagnosis in time for effective intervention. This leads to increased complications (muscle necrosis/amputation) and costs the US healthcare system more than $2.25 B annually. MY01 is capitalizing on a proven correlation between sustained increase in Intramuscular pressures and ACS for objective, early diagnosis. MY01 operationalizes muscular pressure monitoring into a simple, accurate single-use device. MY01. The simple solution to a dangerous problem.