As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation.

The landscape for quality and regulatory affairs (QARA) professionals continues to shift, driven by emerging AI capabilities, changing regulatory compliance frameworks, and an increasingly complex global marketplace.

The evolving regulatory landscape

The global regulatory environment will continue to evolve with a particular focus on AI legislation and the stabilization of key frameworks. We’re witnessing the maturation of European MDR and IVDR requirements alongside U.S. QMSR requirements. Global drivers of change in inspection and enforcement will persist, requiring QARA teams to maintain heightened vigilance and navigate a multitude of site inspections mandated by a range of global regulators.

What’s becoming clear is that industry now recognizes the optimal use of AI: bringing the right data to drive the right insights for outputs defined by global regulations and standards. As companies focus on specific QARA use cases, we’ll see demonstrable benefits in operational efficiency, process effectiveness, resource use, and compliance—all ultimately supporting commercial performance and patient outcomes.

AI and automation in quality documentation

The application of generative AI and automation to quality and regulatory documentation will accelerate in 2026. Whether dealing with policies, procedures, forms, product-complaint investigations, audit reports, or global registration submissions, AI solutions will focus on driving improved process efficiency, quality, and compliance.

First drafts of audit reports, corrective and preventive actions (CAPAs), and complaint investigations can now be generated using AI assistance. Similarly, existing content can be scanned and migrated into different templates for product registration and submission. These capabilities accelerate transactional activities, freeing up QARA professionals to spend more time on high-value professional work instead of administrative tasks.

Design control and compliance by design

A particularly interesting development that will gather momentum in 2026 involves automated tools that scan global legislation pertaining to healthcare products. These systems monitor changes across vertical regulations for medical devices, in-vitro diagnostics, and pharmaceuticals while also tracking horizontal requirements that cross industries, such as cybersecurity, wireless standards, AI regulation, and global data protection requirements.

This dual capability—surveying legislation for changes while supporting the ingestion of specific design inputs for specific product types—enables companies to design for compliance from the outset. It ensures that products have inputs covering global technical, toxicological, and clinical requirements across jurisdictions. This represents a fundamental shift toward ensuring compliance by design, compliance by process, and compliance by culture, all three of which have the core focus of improving end-to-end product quality to ensure patient safety.

Enhanced postmarket surveillance

Medtech can learn from pharmaceutical industry advances in leveraging AI and machine learning for postmarket surveillance. Natural language processing technologies, including generative AI, can screen social media, technical service databases, customer service records, and audio files to improve the capture of adverse events and potential quality issues in both structured and unstructured data.

By embracing these capabilities, medtech companies can achieve better front-end capture to improve case volume, timeliness, and quality. This enhancement will pull through into superior complaint investigations and improved quality and timeliness of adverse event reports, providing companies with better understanding of how products perform in real-world conditions.

AI-enabled change control

Change control represents one of the most compelling use cases for AI in 2026. In my industry experience, approximately 60–70% of global product registration activity involves maintaining the validity of existing registrations, either through cyclical reregistration or content updates based on product, manufacturing, and legislation changes.

An AI-enabled change control process with a robust data backbone can map changes in product design and manufacturing capabilities to reveal effects throughout global activities. Understanding upfront what’s changed, remediation costs, and timelines, along with required actions, improves conscious decision-making around change. It also reduces risks from site-level assumptions filtered through personal bias. Simple changes to labeling, packaging, or customs documentation triggered by manufacturing changes can directly affect product registration in multiple markets—precisely where AI and data can drive informed decision-making.

Integration challenges

Most medtech organizations maintain multiple different systems in their digital ecosystems. Companies grown through mergers and acquisitions often have different systems executing different processes in various divisions, countries, or therapeutic areas. This systemic variation makes integration more complex, with identical fields potentially capturing different information or identical information landing in different fields.

Before driving the digitization that delivers efficiency gains, QARA teams must map processes, data, and systems to chart the journey from current to future state. Data, workflow, and process quite often underpin the success of any technology deployed on top.

Evolving skills and talents

The QARA skill set will continue broadening in 2026 with the growth of software as a medical device allied with the need to understand requirements of AI, cybersecurity, and data protection. Certain core talents of the profession remain essential: critical thinking, effective communication, comfort in being the lone voice with a different opinion on occasion, and that intangible “nose for the job”—instinctively knowing when things don’t feel right, despite what data are presented.

As digital systems focus on execution at scale, QARA professionals will spend more time on strategic critical-thinking activities within core processes. The role itself is changing, potentially attracting a different type of individual to the profession. It’s important that, as technology continues to evolve, human intuition, critical thinking, and experience maintain their seats at the table. That innate contextual awareness can’t be derived from technology systems trained on historic precedent and statistical algorithms.

Global harmonization: Hope vs. reality

While harmonization could significantly simplify go-to-market processes and affect patient access to healthcare, regulation is driven not only by patient safety requirements but also by market evolution, economics, and politics.

Countries exercise sovereign rights, and mutual recognition agreements—where one country accepts another’s products and vice versa—remain elusive. Consequently, operational harmonization faces significant challenges. For example, while the pharmaceutical industry has achieved more than 80% global coverage through electronic common technical document (eCTD) structures for submission and product registration activities, medtech hasn’t yet reached comparable levels of harmonization.

Although harmonization offers clear benefits, political and economic realities present substantial barriers. The IMDRF and its nonenforceable guidelines can continue influencing local legislation, but rapid transformation appears unlikely in the near term.

Balancing innovation with established solutions

While advances in material science, AI, and software drive improved clinical outcomes, we must recognize that well-established technologies already deliver significant patient benefits. Off-the-shelf medical devices, from simple wound-care products to glasses and contact lenses, must maintain their market presence.

Industry needs to drive technological improvements in healthcare while maintaining products that already provide high clinical benefit at an acceptable risk and a controlled cost. The advancement in closed-loop glucose monitoring systems for diabetes management exemplifies transformative technology from systems of the past. But we shouldn’t lose sight of foundational products that continue serving essential needs and are a key part of global healthcare solutions.

Looking forward

The year 2026 promises continued evolution in QARA, combining human expertise with AI capabilities in workflows designed to drive patient outcomes. Success will require balancing technological adoption with human judgment, global standardization aspirations with regulatory realities, and innovation with the preservation of proven solutions. QARA professionals who develop both emerging technical skills and enduring professional talents will be best positioned to navigate this complex landscape and drive a sustained focus on the delivery of safe and effective global healthcare solutions.