SoftServe Completes Successful ISO 13485 Surveillance Audit for Medical Devices and Quality Management Systems


Audit completion reflects company’s proven regulatory compliance and ability to develop quality software as a medical device for clients

AUSTIN, Texas—Dec. 11, 2019SoftServe, a leading digital authority and consulting company, has successfully passed the International Organization for Standardization (ISO) 13485:2016 Surveillance Audit, verifying Quality Management Systems (QMS) that conform to specified requirements and objectives set by the standard. The ISO 13485:2016 certification covers guidelines for a company’s quality management system that demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

“The ISO 13485 audit demonstrates to healthcare providers that SoftServe is dedicated to maintaining the highest level of quality, efficiency, and responsiveness of service provision,” said Alexander Amelin, SVP, client success at SoftServe. “This successful audit shows our compliance with the standard guidelines and enables us to produce safer and more effective medical devices and software while meeting international regulatory requirements and customer expectations.”

The audit was verified by external third-party auditors from Lloyd’s Register, the world’s leading provider of independent assessment services. SoftServe achieved the ISO 13485 certification in October 2018, meeting all specified standards and requirements to guarantee consistent design, development, production, and delivery of medical devices that are safe for their intended purpose.

About SoftServe

SoftServe is a digital authority that advises and provides at the cutting-edge of technology. We reveal, transform, accelerate, and optimize the way enterprises and software companies do business. With expertise across healthcare, retail, media, financial services, software, and more, we implement end-to-end solutions to deliver the innovation, quality, and speed that our clients’ users expect.

SoftServe delivers open innovation—from generating compelling new ideas, to developing and implementing transformational products and services.

Our work and client experience is built on a foundation of empathetic, human-focused experience design that ensures continuity from concept to release.

We empower enterprises and software companies to (re)identify differentiation, accelerate solution development, and vigorously compete in today’s digital economy. No matter where you are in your journey.

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SoftServe Media Contact

Tyler Mahan
Public Relations Manager