Recent Posts by awdesign

QA Consulting Hires Consultant Silas Todd Minnick

QA Consulting Hires Consultant Silas Todd Minnick Accomplished quality professional has extensive knowledge in multiple quality functions Austin, Texas - Feb. 21, 2020 – QA Consulting, Inc. has hired Silas Todd Minnick as a Senior Quality Engineering Consultant. Silas specializes in project management, quality system development, risk management, quality system remediation efforts, and post-market activities.…
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Four Dangerous Myths about Quality that May Cost Lives

Quality is often misunderstood. More specifically, the benefits of a well implemented quality management system (QMS) are not universally known and appreciated, and that can cost lives. Conversely, when executives and manufacturing personnel understand the benefits of a QMS, patient outcomes improve, the quality of life is enhanced, and manufacturers prosper. In the medical devices…
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Five Strategies for Effective Supplier Management

Medical device manufacturers commonly use outsourced suppliers for device components, assembly, packaging, labeling, and sterilization. An outsourced supplier may even produce the entire finished device under the manufacturer’s brand name. In all of these instances, it is ultimately the manufacturer’s (specification developer’s) responsibility, not the outsourced supplier, to ensure that the devices meet all specifications. To meet this responsibility,…
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Human Factors: Integrating the Human Condition into Medical Device Design

Human factors and usability engineering are synonymous terms which describe the application of knowledge about human behavior toward the design of a device. Understanding that human behavior can easily result in adverse events with medical devices, the FDA recently issued the guidance document, Applying Human Factors and Usability Engineering to Medical Devices, to provide recommendations…
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FDA Inspection Trends: A More Collaborative Environment

QA Consulting has identified a shift in perception within the medical device industry regarding FDA inspections in recent years.  Specifically, manufacturers find that the agency’s investigators are fairer in their inspections and more tolerant of gaps when manufacturers demonstrate a proactive commitment to compliance and are actively working to remediate any gaps. The FDA’s data…
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UDI Series: Quality Management System Compliance

Two new sections were added to FDA’s 21 CFR (Code of Federal Regulations) with the release of the Unique Device Identification (UDI) rule in September 2013. Subpart B, Labeling Requirements for Unique Device Identification, was added to 21 CFR 801; and 21 CFR Part 830, Unique Device Identification, was created. http://www.gmppublications.com/Part801.htm  Additionally, several sections of…
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