Author name: ecompliance

Document and Record Management in Regulated Industries ISO 13485:2016 explicitly states that records are a type of document. However, in […]

Revisions to Japan’s Medical Device Quality Management System Ordinance Background and Current Status Japan’s revised Medical Device Quality Management System

Distinguishing Between “Misuse” and “Use Error” in Medical Device Regulation Introduction In the regulatory requirements for medical devices, international standards

Regarding “Heavy” Quality Management Systems Medical device manufacturing and distribution must be fundamentally based on ISO 13485. Particularly when placing

FDA Recognition of ISO 14971:2019 as a Consensus Standard ISO 14971, which defines risk management requirements throughout the medical device

ISO 14971:2019 Revisions – Part 2: Management Responsibility, Risk Analysis, and Risk Management File This column continues the author’s analysis

Revisions to ISO 14971:2019 (Part 1) As previously discussed, ISO 14971 “Medical devices – Application of risk management to medical

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