RAPS Regulatory Convergence 2025: Recommendations for Global Changes and Change Management

By Ken Pilgrim and Evangeline Loh

Managing change in a medical device company or its regulated devices is challenging. Assessing global change can be complicated and involves strategic considerations, including understanding regulatory requirements and requisite regulatory documentation. This helps identify dependencies and timelines. 

The QMS rules

Manufacturers should evaluate their quality management system (QMS) to verify that it can effectively manage process, regulatory and design changes. Monitoring for, and assessment of, changes in regulations, standards and guidance is critical to this process.

Quality planning must be effectively integrated with change control and design and development (D&D) activities to validate that the appropriate sub-processes, activities and deliverables within D&D are identified and included in the change planning. Impacts to D&D inputs, outputs, verification/validation, and risk management must all be considered to produce effective and compliant D&D transfer and design file maintenance.

Process validation and risk management are critical

We recommend that manufacturers maintain a validation master plan to identify when process changes or new processes require validation, including QC test methods. Risk Management Files (RMF) should be treated as the “source of truth” for design, manufacturing and use risks. Keep RMFs updated and referenced throughout the device lifecycle.

Strengthen change control and oversight

Implement a detailed regulatory assessment process within change control to maintain traceability of decisions and actions. Check that management reviews cover quality plans, new/revised regulations, guidance and standards. Conduct internal audits, paying particular attention to verify QMS effectiveness in managing change and maintaining records. Consider focused audits on recently completed significant/complex design changes.

Address global regulatory and intelligence requirements

Manufacturers should document and maintain global change requirements for all jurisdictions, leveraging regulatory databases and local feedback. We suggest that this be augmented with experience from feedback and local representatives. 

And, from a regulatory strategy perspective, consider the feasibility of Predetermined Change Control Plans (PCCP) for U.S. Food and Drug Administration (FDA) submissions. 

In summary

As we have said, regulatory changes need to be assessed individually and by market. Every change is unique and every regulatory system is different, where nuances can be critical to understand in order to be successful. Therefore, a company’s regulatory intelligence capability is also a critical asset. 

A manufacturer’s QMS should be established and maintained to robustly address changes. There are many recommendations for how to check that this is adequately implemented. Continuously monitoring for changes to regulations, standards and guidance is necessary to maintain devices in the market.