Medical device recalls reached an all-time high in 2024, with more than 1,059 recall events.¹ As regulations and enforcement continue to evolve, medtech companies are modernizing their quality controls and processes to enable quality teams to take faster corrective and preventative actions.

The industry’s reliance on outdated platforms, manual processes, and hybrid paper-electronic systems presents growing risks. Quality teams expressed the need for change in the 2025 Veeva MedTech Postmarket Quality Benchmark Report. The research found that 88% of responding medtech organizations are prioritizing postmarket quality modernization within the next three years, implementing scalable technology solutions to support the shift. 

While efforts are underway for many companies, 68% of study participants say they currently rely on manual processes, a combination of paper-based and electronic systems, or legacy on-premise solutions. Outdated systems were cited as the primary barrier to proactive quality management, ranking 1.5 times higher than process or metric gaps. This slows down execution, a risk to addressing product issues and complaints quickly and efficiently. 

Top Drivers for Improving Quality 

Quality transformation is gaining momentum in medtech to reduce risk, improve compliance, and accelerate innovation. The top driver for change, according to 38% of the respondents surveyed, is the need for proactive and risk-based quality management. Given the rise in recalls, a focus on proactive and preventative action can help to streamline postmarket issues.

Establishing scalable operations is another key driver for modernizing quality, with 26% saying it is necessary to support growth and adapt to market changes. Advanced quality systems and processes can help companies meet strategic business objectives to diversify or enter new markets. A scalable quality operation is key, especially as medtech mergers and acquisitions rebounded in 2024² with multiple large deals and an increase in volume. 

Adopting modern technology and meeting new or evolving regulations are important drivers to keep up in a fast-moving industry. Both are key to transforming quality, especially as regulatory changes require new plans and processes to remain compliant. A prime example is the Quality Management System Regulation (QMSR) taking effect in February 2026, an amendment medtech companies have been preparing to meet for over two years. 

The Impact of Technology to Drive Efficiency

Cloud-based quality systems offer compelling advantages, including streamlined workflows, fewer transcription errors, and access to accurate, consistent information in real time. By aligning technology evaluation with clear priorities, like risk-based thinking and scalable processes, medtech companies can drive lasting enhancements in postmarket quality and business growth.

One area where cloud-based quality applications can deliver improvements is complaint resolution and corrective action implementation. With tools that enable collaboration, teams can seamlessly share documents with external stakeholders to accelerate corrective actions. A solution with advanced analytics empowers quality teams to identify trends across product lines and markets, supporting more targeted quality improvement initiatives.

The promise of advanced technologies lies in their capacity to streamline complex workflows and improve operational efficiency, particularly in resource-intensive areas such as patient adverse events management. Application of tools like generative AI, intelligent automation, and robotic process automation have shown slower adoption from only 3% of participating medtech companies. While full implementation remains limited, there is strong optimism these approaches can improve postmarket quality. 

When asked where technology can drive the most impact, respondents said automation for improved timelines and efficiency (75%), connections with other QMS processes (62%), and advanced reporting (61%).

Closing Employee Training Gaps

Current quality training initiatives predominantly focus on policy and procedure review, often neglecting crucial skill development in areas such as risk management methodology, structured problem-solving techniques, and data analysis competencies. The research reflects the gap, with only 19% of respondents saying existing training programs are adequate to support postmarket quality. There is an opportunity to add guidance on job responsibilities to remain productive and compliant.

Digital learning management systems (LMS) can help medtech firms address challenges in training staff, providing interactive, context-specific instruction that dynamically aligns with the latest procedures and regulatory requirements. By integrating LMS with document control systems, companies can synchronize the latest procedures and employee requirements to notify quality staff of changes that affect each role. 

Advanced training tools support the development of specialized competencies required for effective analysis and prevention of product quality issues. These include skills in statistical analysis for trend detection, risk assessment methodologies for evaluating product safety signals, and root cause techniques for addressing complex quality issues. By combining procedural knowledge with analytical skills, organizations can empower quality teams to identify and address potential issues before they impact patients or raise regulatory concerns. 

Optimizing Postmarket Quality Management

The industry’s shift toward modernizing postmarket quality is a direct response to the limitations of the manual processes and legacy solutions that were heavily relied on for execution. By advancing medtech quality operations, leveraging cloud-based tools, exploring emerging innovations, and addressing training deficiencies, organizations can establish a more resilient and efficient quality framework. 

Medtech firms looking to get started with advanced technology, consider: 

Defining clear objectives: Determine specific outcomes, like faster complaint resolution turnaround, quicker CAPA closure, or better audit readiness to guide the technology launch. 

Beginning with high-impact areas: Focus on addressing heavily manual, disconnected, or high-risk quality processes to gain immediate value. 

Aligning cross-functional teams: Engage quality, IT, and business teams early to sync broader transformation priorities with the goals of a technology implementation. 

Leveraging best practices: Learning from successful deployments can improve adoption outcomes and ensure long-term success. 

Syncing technology adoption with both long-term goals and immediate priorities reduces complexity, demonstrates value, and expands adoption over time to drive stronger postmarket quality outcomes and business growth. The changes can foster a culture of continuous improvement and innovation that extends throughout the product lifecycle.

References

1. Sedgwick, State of the Nation: 2024 Product Safety and Recall, 2024.
2. JP Morgan, 2024 Medtech Industry Insights: Investments Trends, M&A Activity, and Market Dynamics, 2025.

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Vishaka Rajaram helps companies advance by bringing together medtech, quality, and technology. She has over 15 years of experience driving digital quality transformations for medtech and biopharma clients and guiding them through ROI-based digital transformation business cases, strategic system selection, and future-state EQS landscape design. She holds a bachelor’s degree in electronics and communications engineering from the University of Madras and an MSE in biomedical engineering from the University of Michigan. She can be reached at vishaka.rajaram@veeva.com.