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Leon Hintzen
Lead Demand Manager
Akzo Nobel

Testing
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Embedded Systems Medical Devices
Wipro has rich experience in testing a variety of medical devices. The team is proficient with the standards defined by regulatory bodies. Wipro's medical testing practice has defined methodologies and created frameworks to provide end-to-end medical device testing solutions.

Wipro provides Compliance & testing services for medical devices with test automation. These services include 21CFR Part 11 Remediation and FDA Verification & Validation for:

  • Patient Monitoring & Drug Delivery System
  • Diagnostic Imaging & Modality Systems
  • Image Management Systems
  • Clinical Diagnostic Devices
  • Medication Delivery Systems
  • Surgical & Life-Assistive Devices

Wipro’s Differentiators

  • ISO 13485 certified for testing of customized software and hardware for medical devices
  • Conformance to ANSI / AAMI SW 68
  • Processes compliant to FDA / CE / MHLW
  • Strong and robust quality framework for medical devices product development, testing and support
  • Certified for ISO 13485 standards
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