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

Global harmonization is a trending topic across the medtech industry. 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,” said Davina Marano, senior international counsel at the FDA’s 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 encourages medtech organizations to standardize document formats, align 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 Scientific, recently sat down with Marano to discuss this topic and share their strategies for making global quality and regulatory harmonization a reality.

Detecting the Gaps to Drive Compliance

For Bio-Rad and Thermo Fisher, the cornerstone of achieving harmonization is working toward consolidating to a single quality management system (QMS).

Bio-Rad has multiple FDA-registered sites and might have written separate quality plans in the past for each location. With the movement toward a single QMS platform, Bio-Rad now has a master quality plan covering all sites.

“We have 14 FDA-registered sites. So, in the past, we might have written 14 quality plans,” Platt explained. “We now only have one.”

Shearstone has been working on a similar initiative at Thermo Fisher on a larger scale to support its 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,” said Platt.

This includes terminology changes, global and local processes, and business functions 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 said. “We are on track to be compliant by the FDA deadline in 2026.”

Shearstone is also conducting a gap analysis, explicitly focusing 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.

“It’s a journey. We have to document our quality plan and ensure we cover quality systems and do things like revised training programs, which we’re also looking at,” added Shearstone.

Navigating Evolving Medtech Regulations

For Bio-Rad and Thermo Fisher, simplifying their technology landscapes is critical to navigating regulation changes like QMSR. Bio-Rad is in the process of consolidating its 37 quality management systems into one QMS.

“We’re looking at technology as a way to enable our harmonization journey,” said 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 complexity across its quality infrastructure. Currently, the company has dozens of applications to support quality management.

“We were struggling with barriers to execution for our team, and maintaining these systems was becoming costly,” said Shearstone.

Thermo Fisher is simplifying its operations by consolidating and will use three main systems for quality management. These simplification efforts may be time-consuming but can amount to long-term cost savings.

“The FDA is required to conduct an economic analysis before publishing new regulations. Our analysis of ISO 13485 showed that it is expected to tremendously reduce costs for industry,” said Marano.

Harmonizing Submissions to Regulatory Agencies

Streamlining regulatory submissions is another initiative medtech companies are prioritizing, especially in the wake of the latest FDA eSTAR update.

“We want to standardize on a Thermo Fisher template, whether for a diagnostic or a device submission,” Shearstone said. “When all the information is standardized, an agency can easily go through the submission when a package comes in.”

“We aspire to use technology to be as effective as possible,” said Platt.

Simplifying the technology landscape at the organization is a significant first step toward harmonization. Establishing a clear vision, building a core team to drive the initiative, defining a governance strategy, and developing a comprehensive change management plan can help medtech organizations get there.

“We’re working to narrow down our portfolio to only certain tools. It’ll make life so much easier for our employees,” said Shearstone. 

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Seth Goldenberg is responsible for the strategic direction of Veeva MedTech. He works across strategy, sales, marketing, services, and product to ensure customer success across clinical, quality, regulatory, and commercialization in the medical device and diagnostic industry. Dr. Goldenberg has 20+ years of experience helping medtech companies navigate complex regulations and improve market access. He holds a doctorate in pharmacology from the University of Washington and a master’s in biomedical engineering from Drexel University.