Category Archives: Quality Systems

QA Consulting, Inc. Presents at TMCx in Houston

Recently one of our Consultants, Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant presented to the newest cohort of start-up medical device companies selected for the Texas Medical Center Accelerator Program (TMCx) in Houston, TX.  The presentation was focused on educating early-stage companies on the key aspects of a medical device quality program. …
Read more

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,…
Read more

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…
Read more

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…
Read more

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…
Read more

Quality Plans as Proactive Tools for Successful FDA Inspections

QA Consulting often advises companies to generate quality plans to ensure that projects are implemented in an organized and comprehensive manner.  In addition to serving as objective planning tools, another inherent advantage of quality plans experienced by some companies has been the avoidance of 483 observations. Illustrated below are two companies QA Consulting recently worked…
Read more