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Digicom Electronics Upgrades Medical Device Quality Certification to ISO 13485:2016
November 27, 2018 | Digicom ElectronicsEstimated reading time: 2 minutes
Digicom Electronics, Inc. has upgraded its medical quality device certification to ISO 13485:2016. 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 specializes in complex products and those that require the utmost precision, reliability, durability, and enhanced performance.
Digicom's Diamond Track Process helps medical device companies with their complete process, from design for manufacturing to fully integrated box build systems. Digicom handles both small runs and high-volume manufacturing and produces the prototype, sources the components, manufactures and tests the product, assists with process validation, and ships the product directly to its end user.
To eliminate device failure from PCB contamination, Digicom uses a proprietary process to clean circuit boards. It removes ion contamination to below detectable levels and results in PCBs that far exceed IPC-TM-650 cleanliness standards. Digicom also manufactures its own nitrogen and pipes it to its manual, reflow, and selective soldering processes to help strengthen the bonds and improve adhesion in the soldering process.
"Manufacturers of medical devices must seek every way possible to eliminate failures of those devices," explained Mo Ohady, general manager of Digicom Electronics. "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; however, among other things, nitrogen can help to strengthen the bond and improve solder adhesion in the soldering process."
Digicom experts will be available at the BIOMEDevice Show, San Jose, CA, on December 5 and 6, in booth 433, to discuss your electronic manufacturing and assembly needs.
Digicom is a certified small business and HUBZone with AS9100:2016 (Rev D) aerospace, ISO 9001:2015, ISO 13485:2016 medical devices quality, quality system regulation 21 CFR 820, and ITAR certifications.
About Digicom Electronics
Digicom Electronics offers advanced electronics manufacturing with "Made in the USA" quality that fits the needs of larger enterprises while at the same time providing the benefits and individual attention needed to serve start-up companies. Digicom collaborates in all aspects of the process from the design for manufacturability to the final, fully compliant product. Material procurement and management services include planning, purchasing, expediting, and warehousing of components and materials. Digicom has been manufacturing in the California Bay Area since 1982. It is a certified small business and HUBZone with AS9100:2016 (Rev D) aerospace, ISO 9001:2015, ISO 13485:2016 medical devices quality, quality system regulation 21 CFR 820, and ITAR certifications.
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