Author name: ecompliance

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

Infrastructure Resource Operational Management (Part 2) Infrastructure Overview ISO 13485:2016 introduced specific requirements for infrastructure to ensure compliance with medical

Resource Operational Management (Part 1) What Are Resources? Resources—often referred to as inputs or assets in quality management—consist fundamentally of

Management Responsibility Why Management Responsibility Is Critical ISO 13485:2016 is an international standard for medical device manufacturers that establishes requirements