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News Release

Dec 5, 2017

Auriga Awarded ISO 13485:2016 Certificate in Medical Software Testing

Woburn, MA, – Auriga, a software R&D outsourcing services provider, is proud to announce that its Quality Management System (QMS) has been assessed and certified as meeting the requirements of ISO 13485:2016 for the software testing of medical devices in November 2017.

Auriga started preparing for the ISO 13485 certification almost two years ago. In accordance with the ISO 13485 requirements, Auriga created a robust and complete QMS for medical device software development and testing, including an ISO 14971 risk management system, and verified it in several real-life projects. In the summer of 2017, Auriga invited a team of auditors to offer their feedback and aligned the QMS with their valuable recommendations. Finally, in November 2017, Auriga was assessed and awarded the Certificate of Compliance.

The company’s General Manager, Vyacheslav Vanyulin, comments:

Auriga constantly strives to take our work up a notch, propel our performance, and ensure the highest quality of developed solutions. Recognized worldwide, the ISO 13485 certificate guarantees the highest level of quality, reliability, and safety for our clients from all over the globe, so it is no wonder we were after this certification to ultimately increase the overall confidence of our customers in the quality of the products we deliver. Being certified, Auriga teams will ensure their continuous growth worldwide and succeed in meeting the very rigorous regulatory requirements.

ISO 13485 is a standalone QMS standard, derived from the internationally recognized and accepted ISO 9000 QMS series that was written to support medical device manufacturers in designing QMSs that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations, and responsibilities and demonstrates a commitment to the safety and quality of medical devices.

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