Author name: ecompliance

Safe Design of Medical Devices: Understanding Risk Management Fundamentals The Three Elements of Design Requirements In general device design, specifications […]

Quality Management System Regulation Amendment: Clarifying Exemptions and Non-Applicability Overview of the Regulatory Change Japan’s Quality Management System (QMS) Regulation,

Common Misconceptions About CAPA (Corrective and Preventive Actions) Introduction: Why CAPA Matters in FDA Inspections During FDA inspections of medical

Misconceptions Regarding “Design Controls” Introduction Since the 1980s, the FDA has imposed stringent regulations on “design controls.” The fundamental reason

Proper Japanese Translation of “Review” in Medical Device Regulatory Requirements: Clarifying Terminology in Quality Management Systems Introduction The term “review”

Competence: Understanding Its True Meaning in Medical Device Regulatory Context Introduction When conducting audits at medical device companies, one of

Understanding Labeling in Medical Device Regulation Distinction Between Label and Labeling Label and labeling are distinct concepts, though a label

FDA Inspections During Government Shutdown Overview The United States federal government experienced a partial shutdown during which government operations were

Following an FDA Inspection Introduction The author recently accompanied a medical device manufacturer through an FDA inspection this month. The

QMS Regulatory Amendment in Japan Introduction On November 25, 2014, the Pharmaceutical Affairs Law was partially amended, and the “Law