Author name: ecompliance

Evolution of Risk Management in Medical Devices: The Significance of ISO 14971 Revision Introduction All medical devices inherently carry some […]

Medical Device Software Development Introduction The development of software (programs) embedded in medical devices requires regulatory requirements that differ significantly

Understanding the Difference Between “Design” and “Design Control” in Medical Devices Throughout my consulting work, I have observed that many

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