On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...

The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes in the regulatory framework for combination drug-device and biologic-device ...

The result is a unified platform that simplifies compliance with the new quality management standards, reduces administrative burden, and strengthens consistency across engagements. “With QualityLink, ...

Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

Doing quality management at scale is a perennial challenge for contact center operators. Today, the average QM coverage rate is just 3%. Insightful's new solution will eventually enable organizations ...

The clock is ticking. Accounting firms that perform engagements under the Statements on Auditing Standards (SASs), Statements on Standards for Attestation Engagements (SSAEs) or Statements on ...

Quality Management Systems boost consistency, compliance, and customer trust. USIQ reviews core QMS principles, ...

Additional featured solutions include: the latest version of the SunCHECK Platform for centralized, standardized Quality Management; SciMoCa™ for Monte Carlo-based independent verification of online ...

All firms that perform accounting or attest engagements must have their new quality management system in place by Dec. 15, 2025. These new standards require firms to develop quality objectives around ...

Invoca achieves 50% year-over-year growth as customers turn to its AI-driven contact center solution to increase agent productivity, improve customer experience, and drive stronger revenue results.