Electrical Engineering Expert Witness Blog
The Safe Medical Devices Act (SMDA)
The Safe Medical Devices Act (SMDA) of 1990 was enacted to strengthen the regulation and post-market surveillance of medical devices in the United States.
Quality System Regulations (QSR)
Quality System Regulations (QSR) play a critical role in ensuring the safety, efficacy, and reliability of medical devices.
Electrical Failures and Personal Injury
Whether due to defective components, poor installation, or environmental factors, these failures present significant legal and technical challenges.
What is Electrical Engineering
Electrical engineering is the backbone of modern technology, powering everything from smartphones to massive power grids.
Current Good Manufacturing Practices (CGMPs)
In the pharmaceutical industry, maintaining product quality, safety, and efficacy is not optional—it’s a regulatory necessity.
Statistical process control (SPC)
Statistical Process Control (SPC) is a powerful methodology used across industries to monitor, control, and improve process quality.
Corrective and Preventive Action (CAPA)
Corrective and Preventive Actions (CAPA) form the backbone of any quality management system (QMS), ensuring continuous improvement and compliance with industry regulations.
Medical Device User Fee and Modernization Act (MDUFMA)
The Medical Device User Fee and Modernization Act (MDUFMA) is a crucial piece of legislation that governs how the U.S. Food and Drug Administration (FDA) regulates medical devices.
