Download the full 2026 Quality + Compliance Trends Report here.

This free industry report outlines industry perspectives and expert advice from our team of quality and compliance consultants. You can view an excerpt of the report below, and if you’d like to discuss any of the above trends or other challenges in the industry, connect with our team today.

Key Quality + Compliance Trends

The landscape of Q+C is shifting to a proactive, patient/consumer–centric approach to improve operations by leveraging other regulatory bodies for decision–making, better patient/consumer interactions, responsible use of AI, and investing in compliance for expansion. All of these work together to create a reliable, repeatable product with efficiency gains and will be key toward enhancing quality in 2026 and beyond.  

Clarkston’s quality and compliance consultants have highlighted the top trends that businesses should consider and keep top-of-mind throughout the year:

1. Scaling Globally: Leveraging Regulatory Harmonization & Reliance for MedTech and Pharmaceuticals Market Expansion
2.  Quality as Customer Experience: How Q+C Teams Can Drive Patient Trust and Loyalty 
3. Responsible AI Compliance: Building Quality into a Digital-First World
4. Investing in Compliance as a Competitive Advantage to Support Growth

Trend 1: 

Scaling Globally: Leveraging Regulatory Harmonization & Reliance for MedTech and Pharmaceuticals Market Expansion  

MedTech (Medical Technology) and pharmaceutical companies are increasingly adopting regulatory harmonization and regulatory reliance to accelerate global market expansion and streamline product launches. Harmonization aligns technical requirements across countries, reducing discrepancies in the approval processes, and enabling regulators to accept shared data submissions, audit results, and surveillance findings.  

A notable example is the U.S. Food and Drug Administration’s (FDA’s) upcoming Quality Management System (QMS) rule, effective February 2, 2026, which aligns U.S. standards with International Organization for Standardization (ISO), reinforcing global consistency in compliance frameworks.  

Regulatory reliance complements harmonization by allowing one country’s regulatory authority to leverage assessments and decisions from another, significantly shortening approval timelines. Programs like the World Health Organization’s (WHO’s) Collaborative Registration Procedure (CRP) enable National Regulatory Authorities (NRAs) to issue decisions within 90 days by relying on documentation from Stringent Regulatory Authorities (SRAs) such as the FDA and European Medicines Agency (EMA). This approach transforms global expansion from fragmented, country-by-country efforts into a strategic, planned sequence of approvals.  

Together, these mechanisms offer companies a competitive advantage when integrated into a compliance-first global strategy. By systemically leveraging harmonization and reliance, organizations can reduce regulatory complexity, accelerate product launches, and position themselves for success in diverse markets worldwide. As we move into 2026, this is evolving from a policy discussion to an important business variable for product approval and market expansion. 

Trend 2:

Quality as Customer Experience: How Q+C Teams Can Drive Patient Trust and Loyalty 

With consumers today becoming more educated and directive about their health, Q+C organizations must evolve from a defensive, audit-focused function into a proactive driver of trust, patient experience, and customer loyalty.  

As consumers and patients increasingly interact with companies through digital tools, wearables, patient services, and real-world data platforms, compliance failures now surface first as customer failures (delays, system outages, or poor communication/confusion) long before regulators are involved. Quality is no longer behind the scenes; it has become a visible part of the patient’s experience, shaping perceptions of reliability, transparency, integrity and trust.  

There are four principles upon which Q+C organizations can base their approach to increase patient trust:  

1. recognizing the patient as the ultimate beneficiary of quality decisions,  
2. treating patient experience as a core quality attribute,  
3. using transparency to build loyalty during quality events, and  
4. fostering a culture throughout the organization where quality is understood as caring for patients rather than avoiding failure.  

By reframing quality activities around human impact and trust, not just regulatory sufficiency, Q+C professionals can position themselves as strategic partners who reduce risk, improve experiences, and help organizations compete on reliability and trust in an increasingly crowded market.  

Continue reading by downloading the full report below.

Download the Full 2026 Quality + Compliance Trends Report Here

Read last year’s Quality + Compliance Trends Report here.

Contributions from Dawid Gil