OAKLAND, Calif.—The electronics manufacturing services company Digicom Electronics, Inc., recently upgraded its medical device quality certification to ISO 13485:2016, the company reported. The ISO 13485 standard is a series of requirements that help device makers develop a quality management system to ensure the quality, safety, and effectiveness of the medical devices they manufacture.
Digicom (https://www.digicom.org/) specializes in complex products that require high precision, reliability, durability, and enhanced performance. Its Diamond Track™ Process helps medical device companies with their complete process, from design for manufacturing to fully integrated box-build systems. Able to handle small runs and high-volume manufacturing, Digicom produces prototypes, sources components, manufactures and tests the product, assists with process validation, and ships the product to its end user.
To eliminate device failure resulting from PCB contamination, Digicom uses a proprietary process to clean circuit boards. The process removes ion contamination to below detectable levels and results in PCBs that far exceed IPC-TM-650 cleanliness standards, the company said in a press release. Digicom also manufactures its own nitrogen and pipes it to its manual, reflow, and selective soldering processes to strengthen bonds and improve adhesion in the soldering process.
“Manufacturers of medical devices must seek every way possible to eliminate failures of those devices,” said Mo Ohady, general manager of Digicom Electronics, in a prepared statement. “Many major failures result from a weakness in the solder joint that connects the wire bond to the printed circuit board, the solder that connects the device or package to the board, or board contamination. That’s why we spent years developing our cleaning process and implementing a nitrogen system. Using nitrogen is not an absolute requirement but nitrogen can help to strengthen the bond and improve solder adhesion in the soldering process.”
Digicom is a certified small business and HUBZone with AS9100:2016 (Rev D) aerospace, ISO 9001:2015, and ISO 13485:2016 medical device quality certifications. The company is also compliant with FDA quality system regulation 21 CFR Part 820 and ITAR.