February 18, 2025, NEW YORK CITY, NY, UNITED STATES
Impelsys, a global leader in technology solutions, is delighted to announce certification for ISO 13485:2016. This international standard for quality management systems (QMS) ensures the safety and reliability of medical devices and related services. This milestone is a testament to Impelsys’ dedication to upholding the highest standards in medical device QA and developing safe, reliable, and innovative healthcare solutions.
“Securing this certification underscores our dedication to robust quality management,” said Vincent Emerald, Head of Quality Assurance. “This accomplishment reflects our team’s tireless efforts to deliver solutions that meet the highest standards of quality and safety in the healthcare industry, ensuring better outcomes for patients and providers alike. This certification also enables us to offer comprehensive Verification & Validation (V&V) services for medical devices.”
Vinod Kumar TV, Chief Operating Officer (COO), added, “This achievement is the result of a rigorous evaluation of Impelsys’ quality management systems, processes, and practices. The certification is an internationally recognized quality benchmark, assuring clients that Impelsys’ solutions meet the high standards of the medical device industry.”
Impelsys provides comprehensive digital solutions to healthcare and this certification further augments its repertoire of transformative solutions, which include Clinical Data Management Services, Healthcare Data Analytics, Application Development, and Learning and Content Solutions.
