One of the ways the FDA enhances safety and improves device performance is through its Voluntary Malfunction Summary Reporting Program. This initiative is instrumental in helping manufacturers, healthcare professionals, and regulators identify and address potential issues before they escalate.
Enterprise Quality & Risk Management Building Resilient Systems That Protect Products, People, And Reputation. We...
In 2026, regulators across major markets are signaling a shift toward risk-based supplier management—and companies that do not adapt may experience delays, compliance findings, or product-quality issues.
As the FDA prepares to implement the long-anticipated Quality Management System Regulation (QMSR)—set to take effect in February 2026—medical device and combination product manufacturers are seeing a noticeable uptick in enforcement tied to inadequate quality systems. The upcoming shift, which harmonizes FDA requirements with ISO 13485:2016, is driving the agency to evaluate whether firms are prepared for a more globally aligned and documentation-intensive framework.
The U.S. Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) has released its seventh annual State of Pharmaceutical Quality report, revealing a marked increase in both foreign and domestic inspections since the COVID-19 pandemic. The data underscores a shift toward heightened regulatory oversight, with significant implications for manufacturers worldwide.
In today’s fast-paced and highly regulated business environment, ensuring operational integrity and compliance is more important than ever. At EMMA International, we specialize in helping businesses navigate the complexities of remediation, providing tailored solutions to address issues like regulatory non-compliance, quality control failures, and process inefficiencies. Remediation is a critical step in ensuring that your operations are aligned with industry standards, protecting both your brand reputation and your bottom line.
This annual report is crucial for understanding how well pharmaceutical manufacturers adhere to quality standards that ensure the safety, efficacy, and availability of medications. Here, we break down the main findings and insights from the report.
It is common knowledge that supplier quality is a critical piece of any MedTech QMS. No matter which regulatory...
ISO 13485 is an International Organization for Standardization (ISO) standard originally developed in the 1990’s, that...
Understanding the key inspection trends shaping FDA oversight in 2026 can help companies strengthen quality systems, improve operational effectiveness, and prepare for future regulatory interactions.