By Ruslan Reva, MDR Manager
When people discuss artificial intelligence, the conversation often focuses on efficiency. While AI certainly helps save time, what interests me most is its ability to help experts manage complexity and make better use of their knowledge.
As Medical Device Regulatory (MDR) Manager, I work with a team responsible for navigating highly detailed regulatory requirements, extensive technical documentation, and products with decades of history. Maintaining compliance requires careful review of information spread across large documentation packages where accuracy and consistency are essential.
Historically, much of this work relied on significant manual effort. Today, AI is helping us approach these challenges in new ways.
Our MDR team began piloting Claude with support from AI Technology Lead Moritz Böttger as we explored opportunities to improve how we manage and review large volumes of documentation. Early results demonstrated how AI could support complex regulatory activities while helping teams work more efficiently.
The team used Claude to assist with MDR submissions that successfully passed completeness checks while significantly reducing the effort required for large-scale document reviews.
One capability that stands out is AI’s ability to maintain context across large projects. Documentation, reference materials, and previous conversations can remain connected, helping teams work through complex challenges without repeatedly starting from the beginning.
AI also supports deeper problem-solving. Rather than simply delivering answers, Claude often asks clarifying questions that encourage critical thinking and uncover considerations that may otherwise be overlooked. That dynamic creates a more productive partnership between technology and the subject matter experts using it.
The value becomes especially clear when looking at how team members apply AI in their daily work.
For example, Systems Engineer Fernando Perez uses AI to review extensive technical files that may contain hundreds of interconnected documents. The technology helps identify inconsistencies, compare information across sources, and surface areas that require expert attention. Instead of spending hours searching for information, engineers can focus their efforts on analysis, decision-making, and risk assessment.
At the same time, successful AI adoption depends on keeping people firmly at the center of the process.
Strong domain expertise remains essential. Clear instructions, reliable source material, and thorough review processes continue to drive quality outcomes. AI can accelerate work and improve access to information, but accountability remains with the professionals responsible for the final result.
This balance between human judgment and AI capability is creating opportunities well beyond regulatory documentation.
Across the team, employees are developing solutions that support project management, generate reports, analyze complex datasets, and organize information more effectively. What makes these examples particularly exciting is that many of them originate with domain experts solving real business challenges. They see an opportunity, experiment with AI, and discover new ways to improve their work.
Looking ahead, I see even greater potential for AI to strengthen collaboration and knowledge sharing across functions. Intelligent assistants could help employees locate information faster, connect expertise more effectively, and support increasingly specialized workflows.
The future of AI in regulated industries is not about replacing people. It is about helping professionals spend less time searching for information and more time applying their expertise where it creates the greatest value.
To me, that is what Innovation that Matters looks like. It is not only about developing new products. It is also about improving how we work. By helping experts navigate complex regulatory requirements more efficiently, AI enables teams to focus more attention on delivering safe, effective medical technologies that support better outcomes for patients and healthcare professionals.