To eQMS or Not: The Enduring Value of a Traditional QMS in a Digital Age
In today’s fast-paced, digital-first world, the allure of electronic Quality Management Systems (eQMS) is undeniable. Streamlined workflows, instant data access, and automated reporting – it all sounds incredibly efficient. But amidst the digital buzz, there’s still a place for the stalwart, traditional paper-based QMS. While often perceived as outdated, a paper system can offer unique […]
Impact of Medical Device Supply Chain Vulnerabilities on Public Health
The U.S. Food and Drug Administration (FDA) is focused on preventing and mitigating medical device shortages, which pose significant risks to patient care, particularly for vulnerable populations like neonatal and pediatric patients. From premature infants in neonatal intensive care units to children with chronic illnesses requiring long-term medical interventions, the need for appropriately sized, high-quality […]
Rethinking eQMS: When a Traditional QMS Might be Right
An eQMS system, or electronic Quality Management System, is a software solution designed to automate and streamline quality management processes within an organization. It replaces traditional paper-based systems with a digital centralized platform for managing documents, workflows, and quality-related activities. While eQMS systems offer automation and streamlined workflows, they aren’t always the best fit for […]
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
FDA recently issued a draft guidance document on “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” . The FDA guidance provides recommendations for sponsors, clinical investigators, and Institutional Review Boards (IRBs) on defining, identifying, and reporting protocol deviations in clinical investigations. While FDA regulations do not explicitly define protocol deviations or classify […]
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies
On January 7, 2025, the FDA issued a draft guidance document on “Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies”. This draft guidance emphasizes the importance of inclusive and representative research to ensure devices are safe and effective for diverse populations. This guidance builds on the previous “Evaluation of Sex-Specific Data in […]
FDA’s Quality Management Maturity Program
In an era where medical devices and pharmaceuticals are becoming increasingly complex, ensuring their safety and efficacy is paramount. The FDA’s Quality Management Maturity (QMM) Program represents a significant step forward in achieving this goal. By focusing on the quality management systems of manufacturers, the QMM Program aims to enhance the overall safety and effectiveness […]
European Commission’s Guidance for Joint Clinical Assessments
In an effort to streamline and enhance the evaluation of health technologies across Europe, the European Commission has released a comprehensive guide focused on the validity of studies for joint clinical assessments (JCAs). This initiative, rolled out under the EU Health Technology Assessment Regulation (HTAR), represents a significant step toward harmonizing the assessment of new […]
The Canadian Artificial Intelligence and Data Act
In an era where artificial intelligence (AI) is rapidly transforming industries and societal norms, Canada has taken a significant step forward by introducing the Artificial Intelligence and Data Act (AIDA). This landmark legislation aims to establish a robust framework for the development and use of AI technologies while ensuring ethical standards, transparency, and accountability. What […]
Navigating the FDA QMSR Transition: Expert Guidance for a Seamless Journey
Are you ready for the FDA’s Quality Management System Regulation (QMSR) transition? The FDA’s new QMSR is set to become effective in February 2026. As a complex regulatory change, it requires careful planning and execution to ensure compliance. Don’t wait — get started now! Why Choose AlvaMed? Our team of experienced quality and regulatory experts […]
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
The FDA has issued a final guidance titled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” This guidance outlines the agency’s policy regarding sterilization site changes for Class III medical devices sterilized using ethylene oxide (EtO). It is intended to address potential or actual disruptions at sterilization facilities that may […]
