FDA, Thermo Fisher Scientific and Bio-Rad: Making Global Harmonization a Reality

At the International Medical Device Regulatory Forum (IMDRF) earlier this year, global harmonization was at the center of several sessions and attendee conversations. But what does harmonization mean? And how can it help organizations comply with the upcoming updates to the Quality Management System Regulation (QMSR) from the U.S. Food and Drug Administration (FDA)?

“Harmonization requires a lot of upfront work, but ultimately it’s a win-win for regulators and industry,” says Davina Marano, senior international counsel at the FDA’s Center for Devices and Radiological Health. “In the long run, it helps us save resources—including time, money, and manpower.” With its recent harmonization efforts, the FDA is encouraging medtech organizations to standardize document formats, align terminology, and work together to improve quality and 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 Scientific, recently sat down with Marano to share their strategies for making global quality and regulatory harmonization a reality. Here are some highlights:

Identifying harmonisation gaps to ensure compliance

For Bio-Rad and Thermo Fisher, the cornerstone of harmonization was working to consolidate into a single quality management system (QMS). “We have 14 FDA-registered facilities. 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 extensive global manufacturing footprint.

Improving quality plans requires Platt and Shearstone to conduct gap analyses to see where changes need to be made to comply with QMSR. “We have a checklist for all of our facilities to assess their procedures,” Platt says. 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 internal audit process. We’re taking this opportunity to create that process,” he says. “We’re on track to be compliant by the FDA’s 2026 deadline.”

Shearstone is also conducting a gap analysis at Thermo Fisher, with a focus on recordkeeping and labeling. To manage the initiative, Thermo Fisher has implemented a management structure that meets monthly to ensure the company is ready for February 2026. Shearstone said, “It’s a journey. We have to document our quality plan and make sure we’re covering quality systems and do things like revised training programs, which we’re also looking at.”

Using Technology to Navigate Health Technology Regulations

For Bio-Rad and Thermo Fisher, simplifying their technology landscapes is key to navigating regulatory 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,” Platt says. “This was a great opportunity for us to take stock of our processes on a global scale.”

Thermo Fisher is also looking to reduce technology complexity. The company currently has dozens of different quality management applications. “We were struggling with a lot of barriers to getting our team to do their jobs, and we were spending a lot of money to maintain those systems,” Shearstone says. “We took a top-down approach and decided that Veeva Vault was one of three major systems we were going to implement across the company.”

These simplification efforts can take time, but they will result in long-term cost savings. “The FDA is required to conduct an economic analysis before issuing new regulations. Our analysis of ISO 13485 showed that it is expected to significantly reduce costs for industry,” Marano says.

Standardization of regulatory filings

Thermo Fisher and Bio-Rad are also working to streamline regulatory submissions, especially with the FDA’s latest eSTAR update. “We want to standardize the Thermo Fisher template, whether it’s a diagnostic submission or a device submission,” Shearstone says. “Once all the information is standardized, the agency can easily review the submission when the package arrives.”

Bio-Rad is also exploring how technology like Vault RIM can help it harmonize its regulatory processes. “We aspire to leverage technology as effectively as possible,” Platt says. Shearstone adds, “We’re working to narrow down our portfolio to just a few tools. That will make life a lot easier for our employees.”

Watch the full session on Veeva Connect to learn more about the harmonization that Bio-Rad and Thermo Fisher experienced.