The new report details how life sciences organizations are responding to regulatory change, resource constraints, and fragmented systems.

St. Paul, MN — March 10, 2026 — Grand Avenue Software has released its 2026 Quality, Compliance, & Operations Trends Survey Report, providing new data on how medical device, diagnostics, pharmaceutical, biotech, and contract manufacturing organizations are responding to rising regulatory expectations and operational pressures.

Based on hundreds of survey responses from QA, Regulatory Affairs, and medical manufacturing professionals, the report highlights wide variation in FDA‑QMSR readiness, persistent quality improvement‑ challenges, and escalating operational risks, including supply chain strain, skilled labor shortages, and fragmented data systems. The findings also reveal uneven digital maturity, with significant differences in eQMS adoption, cross-functional collaboration, and confidence in system scalability.

“Life Sciences organizations are navigating simultaneous regulatory and operational demands, and this year’s data shows just how uneven readiness is across the sector,” said Ron Schmitz, President & CEO of Grand Avenue Software. “The report gives leaders a clear benchmark to guide planning and investment in 2026.”

The full report is now available for download on www.grandavenue.com and includes detailed comparisons and insights to help life sciences organizations strengthen quality systems, improve regulatory readiness, and reduce operational friction.

About Grand Avenue Software
Grand Avenue Software provides modular quality management solutions for life sciences organizations, helping teams streamline compliance, reduce documentation burden, and strengthen audit readiness. With two decades of industry experience, the company supports medical device, diagnostics, pharmaceutical, and biotech organizations seeking to modernize quality systems and accelerate innovation. For more information, visit www.grandavenue.com.

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Grand Avenue Software helps MedTech teams modernize documentation, training, audits, and complaints and remain aligned with ISO 13485 and the new QMSR.

Talk to our team to learn how Grand Avenue can help you stay audit-ready, investor-ready, and market-ready.