From October 7 to 9, the Vistatec Life Sciences team had the pleasure of attending RAPS Convergence 2025 in Pittsburgh, Pennsylvania. As one of the most influential gatherings in the regulatory affairs space, the event brought together professionals from across the medical device, pharmaceutical, and biotech industries to share knowledge, solve complex problems, and plan for the future.
Representing Vistatec were Karen Tkaczyk, Maria Mateos, and Maria Roa. The team hosted a booth, attended expert-led sessions, and participated in several networking events and dinners. It was a rewarding few days, filled with engaging conversations and new opportunities.
Our presence at RAPS reflects Vistatec’s long-term commitment to supporting life sciences companies with high-quality, compliant localization services. Preparing regulatory submissions and developing clear, culturally appropriate patient materials are just a few of the ways we can help make communication effective across markets and languages.
Here are some of the key themes and takeaways our team brought back.
What Is Driving Regulatory Affairs in 2025
Artificial Intelligence and the EU AI Act
AI continues to gain traction in regulatory operations. It is being used for automation, content generation, data handling, and more. However, throughout the sessions, it was clear that the message is still that human oversight is essential.
With the EU AI Act on the horizon, companies are being encouraged to assess how they utilize AI within regulatory processes and ensure that their systems are properly validated. AI may help speed things up, but compliance and patient safety must always remain the top priority.
MDR and IVDR Updates Are Coming, but No Shocks Expected
Many conversations at RAPS focused on the anticipated updates to MDR and IVDR. While final guidance is expected before the end of the year, early feedback suggests no significant changes are in the works. Instead, the revisions will aim to improve evaluation efficiency and reduce unnecessary costs.
Importantly, existing compliance deadlines are not expected to shift. Life sciences organizations should stay on course with their current timelines and continue preparing as planned.
Common Gaps in Technical Documentation
Several panelists pointed out recurring issues in regulatory submissions. Incomplete documentation, inconsistencies across files, and missing or unclear justifications were identified as barriers to successful approvals.
To reduce the risk of rejection or delay, organizations need strong internal collaboration. Departments should not operate in silos. Regulatory affairs, quality assurance, and localization teams all need to be involved from the start. Experts recommended using detailed checklists and holding thorough internal reviews before submission.
Vistatec Life Sciences supports this integrated approach. Our clients know that building in localization and linguistic quality from day one improves not only clarity, but the overall strength of the submission.
CE Certificate Renewal: A Call for Practicality
Another area of discussion was the CE marking recertification cycle. Many industry voices are questioning whether the current five-year cycle is appropriate for technologies that have already demonstrated long-term safety and performance.
There is also a push to broaden the definition of “established technology,” which could give regulators more flexibility when assessing products that are well-known and stable in the market.
Any changes in this area could reduce manufacturers’ workloads without compromising standards.
Wrapping Up
RAPS Convergence 2025 was a productive and energizing experience for the Vistatec Life Sciences team. We were able to exchange ideas with colleagues, hear firsthand about regulatory trends, and explore how language services can help teams succeed in this global industry.
We want to thank everyone who visited our booth, met us at dinner, or stopped to chat. It is always a pleasure to be part of a community that is working hard to improve lives through safe, effective, and innovative health products.
If you would like to learn more about how Vistatec Life Sciences supports global regulatory communications, reach out to our team. We are always happy to help.
