New York, London, Munich, Dubai – November 21, 2024 – DataArt, a global software engineering firm, today announced it has obtained the ISO 13485 certification as a Medical Device Software Supplier, achieving a critical milestone for quality and regulatory compliance in the HealthCare and Life Sciences (HCLS) domain. Granted by DQS Medizinprodukte GmbH, this certification follows an in-depth audit confirming that DataArt's Quality Management System adheres to the ISO 13485 standard for medical software design, development, deployment and maintenance.
This certification represents DataArt's commitment to delivering the highest quality and safety standards in Software as a Medical Device (SaMD) development, assuring clients that their projects meet stringent regulatory requirements and industry best practices. It offers practical benefits, including streamlined supplier management, which saves clients time and resources through simplified audits and evaluations, and efficient collaboration, allowing clients to work seamlessly with DataArt without additional protocols or training on quality systems.
Ivan Pantykin, Vice President, Healthcare and Life Sciences, Europe at DataArt, said:
“We're proud to have achieved this certification, which reflects our commitment to quality and safety in Software as a Medical Device sphere.
We see ourselves as true partners for progress. This certification strengthens our ability to help clients bring reliable, compliant medical solutions to market and reinforces our role as a trusted ally in their success.”
Commitment to Quality Across Operations
The obtained certificate currently covers DataArt’s Wroclaw office in Poland. However, the company is committed to upholding these standards across all its operations, ensuring clients receive the same high-quality service no matter where projects are staffed.
With its new ISO 13485 certification, DataArt reinforces its reputation as a trusted partner in the medical device space, blending deep regulatory expertise with a commitment to quality that drives value for clients in a complex and regulated industry.
