2026 Benchmark Report
Medical Quality & Compliance Survey Results
How life sciences organizations are navigating FDA-QMSR readiness, design control, post-market surveillance, and eQMS adoption in 2026.
Executive Summary
Five Themes From the 2026 Survey Data
Regulatory pressure is rising faster than readiness
More than half of organizations are only moderately or not prepared for FDA-QMSR, making inspection readiness and QMS upgrades urgent priorities.
Quality teams are stretched thin
Resource constraints, resistance to change, and leadership alignment gaps remain the biggest blockers to improving quality and accelerating development.
Fragmented systems slow innovation
Managing information across disconnected tools, ensuring traceability, and documenting work are the most painful design-control activities.
Operational friction is widespread
Regulatory complexity, supply chain instability, data silos, and rising material costs continue to strain manufacturing performance.
Digital transformation is the clearest path forward
Organizations see the greatest impact coming from modernized QMS processes, integrated digital tools, stronger training, and more unified leadership engagement.
Survey Methodology
How the Data Was Collected
Audience
Quality, regulatory, and operations professionals across MedTech, pharmaceuticals, diagnostics, biotech, and contract manufacturing.
Format & Questions
Online survey (SurveyMonkey) with single-select, multi-select, and open-ended questions.
Focus Areas
FDA-QMSR preparedness, regulatory gaps, design control, post-market surveillance, quality tools, and eQMS satisfaction.
Sample
269 total responses collected during the January 2026 fielding period.
Respondent Profile
Product Categories
What types of life sciences products do respondents work on?
Medical devices represent the dominant segment in this report. Pharmaceuticals and diagnostics also appear frequently, indicating a mix of device- and drug-focused organizations, with a meaningful share in contract manufacturing and SAMD.
Section 01
Regulatory & Quality Gaps
FDA-QMSR Preparedness
How Prepared Are Organizations?
How prepared are organizations for FDA-QMSR implementation?
- Highly prepared46%
- Moderately prepared36%
- Low / not prepared / unaware18%
Readiness for FDA-QMSR is uneven. While a portion feel highly prepared, more than half (54%) report only moderate or low preparedness — or are unaware of the regulation entirely — indicating significant gaps in training, process updates, and regulatory alignment.
Regulatory Gaps
Biggest Compliance Gaps
Which regulatory areas represent the biggest compliance gaps? (Top 5)
Respondents could select up to three options. Percentages represent the share of respondents selecting each option.
Quality Improvement Challenges
What Most Affects Quality Improvement
Which challenges most affect quality improvement efforts? (Top 5)
Resource constraints are the most frequently cited barrier — teams are stretched thin. Leadership buy-in and resistance to change appear consistently, suggesting cultural challenges remain a major blocker. Validation burden is a notable friction point for teams considering new tools.
Respondents could select up to three options.
Quality Management Collaboration
How Collaborative Is Quality Management?
How collaborative is quality management across organizations?
- Highly collaborative45%
- Moderately collaborative46%
- Siloed or very siloed9%
A meaningful number of respondents (55%) describe their organization as siloed/very siloed or moderately collaborative, which often correlates with data fragmentation and slower decision-making.
Quality & Regulatory Priorities
Top Priorities for the Next 12 Months
What are the top quality and regulatory priorities for the next 12 months? (Top 5, ranked)
Preparing for inspections / audits
Upgrading QMS processes
Gaining market approval
Improving data tracking / trending
Clinical evaluations / PMCF
Inspection readiness is a major focus, especially with QMSR changes on the horizon. Upgrading QMS processes is a leading priority, aligning with findings about tool limitations and process pain points. Market approval and better data tracking highlight the need for improved visibility and analytics across the product lifecycle.
Section 02
Innovation & Design Control
Drivers of Innovation
The Biggest Driver of Innovation Today
What’s the single biggest driver of innovation today?
Customer input is the strongest driver of innovation, underscoring the industry’s shift toward user-centered design. Internal R&D also plays a major role, while competitive pressure and regulatory requirements serve as secondary motivators.
Painful Design Control Activities
Most Painful Design Control Activities
What are the most painful design control activities? (Top 5, ranked)
Managing information across systems
Documenting work throughout new product development
Ensuring traceability
Understanding the requirements needed
Managing change approvals
Managing information across systems and ensuring traceability frequently appear as top pain points — both symptoms of fragmented tools and manual workflows. Documentation burden and change approvals further slow development cycles and increase compliance risk.
Section 03
Post-Market & Operations
Post-Market Surveillance Preparedness
Ready to Manage PMS at Scale?
How prepared are organizations to manage post-market surveillance at scale?
- Very prepared39%
- Somewhat or not prepared61%
Over half of respondents (61%) feel somewhat or not prepared to scale post-market surveillance, signaling gaps in trending, complaint handling, and data integration. A smaller group (39%) reports being very prepared, typically larger or more mature organizations.
Operational Challenges
Top Operational Challenges Right Now
What are the top operational challenges right now? (Top 5)
Respondents could select up to three options.
Section 04
Tools & Technology
Quality Management Tools
What Tools Do Organizations Use?
What type of tools do organizations use for quality management?
- Purpose-built eQMS42%
- General-purpose (Excel, SharePoint)40%
- Paper-based18%
58% report no purpose-built eQMS usage. General-purpose tools like Excel and SharePoint, along with paper-based processes, remain common — indicating that many teams still operate without fully integrated digital systems.
Confidence in eQMS Scalability
Can Current Software Scale?
How confident are organizations that their current software can scale over the next 12 months?
- Very confident52%
- Somewhat or not confident48%
Nearly half (48%) are only somewhat or not confident that their current quality management software can scale in the next year, signaling potential gaps in integration, workflow automation, and data management.
Barriers to Adopting eQMS
What Prevents Adoption?
What prevents organizations from adopting purpose-built eQMS tools?
Cost and implementation time are the biggest barriers to adopting purpose-built eQMS solutions. Integration challenges and internal resistance also slow adoption, especially for teams with legacy systems or limited training resources.
Respondents could select up to three options.
Section 05
Open-Ended Insights
Biggest Operational Obstacle
What Would Organizations Remove Today?
Four obstacles consistently surfaced as the biggest barriers to smooth operations:
Fragmented Systems & Manual Processes
Too many disconnected tools, paper-based workflows, and inconsistent information create inefficiency.
Regulatory & Compliance Complexity
Changing requirements, global inconsistencies, and long approval timelines add operational friction.
Resource & Staffing Gaps
Limited personnel, skill shortages, and budget constraints slow progress.
Leadership Challenges
Unclear ownership, slow decisions, and inconsistent leadership alignment hinder momentum.
Biggest Opportunity for Impact
Where the Biggest Gains Will Come From
Four clear opportunity areas emerged from open-ended responses:
Quality, Compliance & Regulatory Readiness
Improving QMS processes, harmonizing requirements, and strengthening documentation and CAPA.
Digital Transformation & Automation
AI, automated workflows, integrated systems, and reducing paper to boost efficiency.
Training & Workforce Development
Stronger training, better regulatory education, and developing skilled personnel.
Leadership Alignment & Collaboration
Clearer decisions, stronger leadership engagement, and better cross-functional teamwork.
Recommendations
How Organizations Can Modernize
The data highlights clear opportunities to modernize quality systems, strengthen collaboration, and improve readiness for evolving regulatory demands.
Process
- Modernize design-control workflows
- Upgrade QMS processes for FDA-QMSR alignment
- Improve cross-functional collaboration to reduce silos
People
- Strengthen training and regulatory education
- Build workforce capability to address resource constraints
- Foster a culture that reduces resistance to change
Technology
- Invest in scalable, integrated eQMS tools
- Enhance data visibility for trending and PMS
- Automate manual workflows to reduce compliance risk
Leadership
- Strengthen leadership alignment and ownership
- Prioritize QMSR preparedness at the executive level
- Champion digital transformation for long-term resilience
Quality That Frees Innovation
Grand Avenue Software helps life science companies innovate faster by removing documentation chaos, compliance friction, and audit risk. Our modular QMS lets you start with what you need today and scale effortlessly — with 20 years supporting life science quality teams.