At the International Medical Device Regulators Forum (IMDRF) earlier this year, global harmonization was at the center of several sessions and attendee conversations. But what does harmonization entail? And, how can it help organizations comply with looming Quality Management System Regulation (QMSR) updates from the U.S. Food and Drug Administration (FDA)?
“Harmonization requires a lot of upfront work, but it is ultimately a win-win for regulatory bodies and the industry,” says Davina Marano, senior international counsel at the FDA Center for Devices and Radiological Health. “In the long run, it helps us conserve resources – including time, money, and manpower.” With its recent harmonization efforts, the FDA is encouraging medtech organizations to standardize document formats, align on terminology, and collaborate to improve quality and regulatory compliance.
Elizabeth Platt, vice president of regulatory and clinical affairs at Bio-Rad Laboratories, and Peter Shearstone, vice president of global quality and regulatory affairs at Thermo Fisher, recently sat down with Marano to share their strategies for making global quality and regulatory harmonization a reality. Here are the highlights:
For Bio-Rad and Thermo Fisher, the cornerstone of harmonization has been working toward consolidating to a single quality management system (QMS). “We have 14 FDA-registered sites. So, in the past, we might have written 14 quality plans,” Platt explains. “But now, we only have one.” Shearstone has been working on a similar initiative at Thermo Fisher, but on a larger scale to support their expansive, global manufacturing footprint.
Streamlining their quality plans requires Platt and Shearstone to conduct gap analyses to see where they need to make changes for QMSR compliance. “We have a checklist for all of our sites to assess their procedures,” says Platt. This includes terminology changes, global and local processes, and business functions that were not previously subject to FDA inspections. “For example, we didn’t have a single global procedure for internal audits. We’re taking this opportunity to create that process,” she says. “We are on track to be compliant by the FDA deadline in 2026.”
Shearstone is also conducting a gap analysis at Thermo Fisher, with a specific focus on control of records and labeling. To manage this initiative, Thermo Fisher implemented a governance structure that meets monthly to ensure the company is ready for February 2026. Said Shearstone, “It’s a journey. We have to document our quality plan and make sure we cover quality systems, and do things like revised training programs, which we’re also taking a look at.”
For Bio-Rad and Thermo Fisher, simplifying their technology landscapes is key to navigating regulation changes like QMSR. Bio-Rad is in the process of consolidating its 37 quality management systems into Veeva Vault QMS. “We’re looking at technology as a way to enable our harmonization journey,” says Platt. “It’s been a great opportunity for us to take stock of our processes on a global scale.”
Thermo Fisher is also looking to reduce technological complexity. Currently, the company has dozens of different quality management applications. “We were struggling with a lot of barriers to execution for our team and spending a lot of money maintaining these systems,” says Shearstone. “We took a top down approach and decided that Veeva Vault is one of the three main systems that we’re going to allow in our company.”
These simplification efforts may be time-consuming, but they will amount to long-term cost savings. “The FDA is required to conduct an economic analysis before we publish new regulations. Our analysis of ISO 13485 showed that it is expected to tremendously reduce costs for industry,” says Marano.
Thermo Fisher and Bio-Rad are also working on streamlining regulatory submissions, especially in the wake of the latest FDA eSTAR update. “We want to standardize on a Thermo Fisher template, whether it’s for a diagnostic or a device submission,” Shearstone says. “When all the information is standardized, an agency can easily go through the submission when a package comes in.”
Bio-Rad is also looking into how technology like Vault RIM can help them harmonize their regulatory processes. “We aspire to use technology to be as effective as possible,” says Platt. Shearstone adds, “We’re working to narrow down our portfolio to only certain tools. It’ll make life so much easier for our employees.”
Watch the full session on Veeva Connect to learn more about Bio-Rad’s and Thermo Fisher’s harmonization journeys.