Healthcare resilience goals and regulatory frameworks accelerate adoption of AI-enabled medical technology solutions, ISG Provider Lens® report says
LONDON, October 28, 2025–(BUSINESS WIRE)–European medical device companies are carrying out digital transformations to modernize regulatory operations, strengthen post-market surveillance and improve patient safety, according to a new research report published today by Information Services Group (ISG) (Nasdaq: III), a global AI-centered technology research and advisory firm.
The 2025 ISG Provider Lens® Medical Device Digital Services report for Europe finds that enterprises are using digital platforms and solutions to optimize their operations in response to aging populations, evolving regulation and rapid technological change. Among other changes, they are upgrading product quality and vigilance systems to meet the European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) standards and automating regulatory documentation, compliance reporting and post-market monitoring.
“European medical device makers are realizing measurable results from digital transformation,” said Sven Geissler, director at ISG. “They are reducing costs and improving device performance while strengthening the return on their technology investments.”
Device companies are expanding remote-care capabilities as part of a broader shift toward patient-centered models. Telemedicine and connected monitoring tools help support aging populations and manage chronic diseases while meeting mandatory timelines. Integrated patient engagement platforms collect feedback and track adherence, improving oversight and responsiveness. Adoption of new technologies and approaches has been faster in Western Europe, but Eastern Europe’s medical device industry is emerging as companies invest in compliance operations, regional regulatory intelligence and multilingual hubs for post-market reporting.
Enterprises are adopting GenAI to support regulatory submissions, vigilance reporting and quality documentation, reducing manual effort and improving accuracy, the report says. They are also deploying digital twins and advanced analytics to validate device performance and predict potential component failures, improving device reliability and safety. Upgraded digital quality management systems track corrective actions and audit findings in real time, enabling faster regulatory responses and stronger compliance outcomes.
Many device makers in the region are collaborating with service providers on operations and preparing for new generations of technology. Co-innovation labs are accelerating usability testing and device validation, improving safety and audit outcomes. Outcome-based provider pricing models, which tie fees to results such as regulatory approvals and complaint resolution timelines, are gaining traction with clients.
“Enterprises that align compliance with innovation are achieving greater operational stability and market access,” said Sneha Jayanth, lead analyst, ISG Provider Lens Research, and lead author of the report. “Validated AI tools, compliance-ready cloud platforms and secure data pipelines are quickly becoming mandatory capabilities for medical device manufacturers.”
The report also explores other trends in Europe’s medical device industry, including the increasing adoption of digital-first quality management systems and the integration of sustainability goals into regulatory strategies.
For more insights into challenges relevant to medical device digital services in Europe, plus ISG’s advice for overcoming them, see the ISG Provider Lens® Focal Points briefing here.
The 2025 ISG Provider Lens® Medical Device Digital Services report for Europe evaluates the capabilities of 21 providers across three quadrants: Digital Engineering and Product Development, Regulatory Compliance, Strategy and Quality Assurance, and Post-Market Digital Enablement.
The report names Accenture, Cognizant, HCLTech, Infosys, TCS and Wipro as Leaders in three quadrants each. It names Capgemini as a Leader in two quadrants. Deloitte and LTTS are named as Leaders in one quadrant each.
In addition, LTTS is recognized as a Rising Star — a company with a “promising portfolio” and “high future potential” by ISG’s definition — in two quadrants. HARMAN is named as a Rising Star in one quadrant.
The 2025 ISG Provider Lens® Medical Device Digital Services report for Europe is available to subscribers or for one-time purchase on this webpage.
About ISG Provider Lens® Research
The ISG Provider Lens® Quadrant research series is the only service provider evaluation of its kind to combine empirical, data-driven research and market analysis with the real-world experience and observations of ISG’s global advisory team. Enterprises will find a wealth of detailed data and market analysis to help guide their selection of appropriate sourcing partners, while ISG advisors use the reports to validate their own market knowledge and make recommendations to ISG’s enterprise clients. The research currently covers providers offering their services globally, across Europe, as well as in the U.S., Canada, Mexico, Brazil, the U.K., France, Benelux, Germany, Switzerland, the Nordics, Australia and Singapore/Malaysia, with additional markets to be added in the future. For more information about ISG Provider Lens research, please visit this webpage.
About ISG
ISG (Nasdaq: III) is a global AI-centered technology research and advisory firm. A trusted partner to more than 900 clients, including 75 of the world’s top 100 enterprises, ISG is a long-time leader in technology and business services that is now at the forefront of leveraging AI to help organizations achieve operational excellence and faster growth. The firm, founded in 2006, is known for its proprietary market data, in-depth knowledge of provider ecosystems, and the expertise of its 1,600 professionals worldwide working together to help clients maximize the value of their technology investments.
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