Hexaware Named a Rising Star in the ISG Provider Lens® Medical Device Digital Services 2025 U.S. Quadrant Report

Information Services Group (ISG), a leading global technology research and advisory firm, has recognized Hexaware as a Rising Star in the Regulatory Compliance, Strategy and Quality Assurance quadrant of its ISG Provider Lens® Medical Device Digital Services – U.S. Quadrant 2025 report.

The report evaluates service providers on their ability to support digital transformation across the medical device value chain. Hexaware’s recognition reflects its growing strength in applying AI-driven regulatory intelligence, quality automation, and post-market surveillance to help medical device manufacturers meet stringent global compliance requirements.

“Hexaware applies AI-driven regulatory intelligence, cloud-native platforms, and integrated quality systems to support medical device manufacturers. Its approach enables smoother regulatory submissions, proactive post-market surveillance, and secure audit readiness, while helping organizations adapt to evolving requirements and maintain a strong focus on patient safety.” — Rohan Sinha, Report Author, Senior Manager and Principal Analyst, ISG

Regulatory Compliance, Strategy and Quality Assurance: AI-led Compliance at Scale

In this quadrant, ISG assessed providers on their ability to help medical device manufacturers navigate frameworks such as FDA QMSR, EU MDR, ISO 13485, and IEC 62304 while ensuring faster approvals, audit readiness and sustained quality.

ISG highlighted Hexaware’s innovative use of AI-driven regulatory and quality platforms that simplify submissions, ensure QMS compliance and automate post-market surveillance, enabling medical device manufacturers to accelerate innovation with confidence.

Key highlights from the report include:

• AI-driven Regulatory Intelligence:
  Hexaware’s Medical Device intelligent platforms synthesize regulatory data to enable precise content extraction and regulatory synthesis while ensuring submission readiness and QMS compliance.
• Innovative Regulatory Intelligence Platforms:
  Using AI, Hexaware streamlines submissions across 65+ markets, adhering to FDA and EMEA guidelines. These cloud-native solutions anticipate regulatory changes, improve document collation, and provide real-time compliance checks.
• Integrated Quality Management Solutions:
  Hexaware’s electronic QMS helps manufacturers achieve audit readiness and streamline document control and training. With AI-driven regulatory intelligence, it ensures proactive adaptation to evolving EU MDR and ISO 13485:2016 requirements, enhancing patient safety.
• Post-market Surveillance Automation:
  Hexaware automates post-market surveillance using AI, enabling clients to monitor device performance and detect adverse events in compliance with FDA and MDR/IVDR standards. Its AI- and blockchain-powered remote-audit solutions further enhance compliance readiness and efficiency.

A Rising Star in MedTech Transformation

Hexaware’s inclusion as a Rising Star underscores its progress and innovation in regulatory intelligence and compliance automation. By combining domain expertise with AI-powered platforms, Hexaware is helping medical device firms enhance safety, ensure quality, and accelerate market readiness.

Hexaware Named a Rising Star in Regulatory Compliance, Strategy, and Quality Assurance in the ISG Provider Lens® Medical Device Digital Services 2025 – U.S. Quadrant Study

“With Hexaware’s advanced platforms, regulatory complexity becomes an opportunity for strategic advantage, driving efficiency and ensuring safety in product development.” — Rohan Sinha, Report Author, Senior Manager and Principal Analyst, ISG

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