Wipro Connected Services – QARA

Regulatory bodies such as the FDA, EU MDR, and MDSAP have released hundreds of new and updated regulations, with more than half introduced in recent years. Regulatory teams spend significant effort tracking and interpreting these changes due to the lack of a unified regulatory intelligence platform.

Wipro Connected Services QARA provides a smart, centralized regulatory platform powered by AI and automation to support end‑to‑end quality assurance and regulatory affairs across the medical device lifecycle.

End‑to‑End Regulatory Lifecycle Coverage

• Ideation Phase – Automated regulatory assessment to identify applicable compliance requirements (FDA, EU MDR, MDSAP)
• Market Research – LLM‑based regulatory intelligence to assess compliance in target markets across device connectivity, features, and data reliability
• Concept Development – Automated regulatory matrix for requirement traceability with FDA and MDR guidelines
• Design & Prototype – Automated design review aligned with Design Qualification standards (ISO, CFR, IEC)
• Regulatory Approval – Automation suite for preparing and submitting regulatory filings (510(k), CE Mark) and automated QMS validation
• Clinical Trials, Product Launch, and Post‑Market Surveillance

Technology & Architecture Wipro Connected Services QARA solutions are built on AWS Cloud and leverage AWS native services such as Amazon HealthLake, Amazon Bedrock, and Amazon Athena to enable scalable, secure, and compliant regulatory operations.

Wipro Connected Services Offerings

• Regulatory Advisory and Transformation Services
• Design Consulting and Assurance
• Usability Engineering
• Risk, Process Assurance, and Compliance
• Quality Management System (QMS)
• Global Product Launch Support
• Post‑Market Assurance