Argo Translation Receives ISO 13485:2016 Registration

Argo Translation has added ISO 13845:2016 registration to its repertoire of quality management systems, ensuring that Argo’s translation work for the medical devices industry meets this internationally agreed-upon standard.
 
The International Organization for Standardization states that “safety and quality are non-negotiables” in the medical devices field, a position Argo Translation firmly supports. “Being ISO-certified is another step in showing our commitment to this industry and the role Argo plays in medical device translation services,” said Argo founder Peter Argondizzo.
 
“Since we already have ISO 9001 and ISO 17100 registrations, we are comfortable with the implementation of quality management systems,” he said. “We already met a lot of the requirements, especially concerning traceability of the translation, which is one of the most important components. Having an audit trail on all translations is a vital requirement for many of our clients and one we have been meeting for more than a decade now.”
 
Quality and efficiency are key in the complex process of translating for the medical devices industry, especially regarding compliance with regulatory initiatives. Argo’s Regulatory Compliance Platform (RCP) provides secure online access and reporting capabilities to support translation and localization procedures for a complete audit trail on every project.
 
“We have a deep understanding of the accuracy required to work in the medical devices field. Argo has clients who make defibrillators, bedside monitors, and HIV testing devices. The stakes are high, and obtaining this registration is one way we can clearly communicate our level of dedication to quality,” Argondizzo said.
 
Argo Translation’s ISO registrations now include ISO 9001:2015, ISO 17100:2015, and ISO 13485:2016. “These certifications ensure that we are prepared to handle translation projects for the manufacturing and medical device industries with the strictest regulatory guidelines,” Argondizzo said.
 
Argo Translation provides specialized and professional language translation services for all industries. With teams of linguists around the world, Argo is able to capture not only the technical meaning but also the appropriate and necessary cultural understanding for all translations. Dedicated project management teams, updated technology, and professional translators help businesses connect across language barriers in all domains, including legal, technical, marketing, financial, and more. Argo Translation is a complete translation department for businesses around the world.