Author name: ecompliance

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

Understanding State of the Art: The Latest Technology Standards Definition and Essence of State of the Art The phrase “State

What is Inspection Review?: Systematic Review Processes That Drive Quality Improvement Overview of Inspection Review and Its Value In software

Why Planning Documents Require Continuous Updates Modern Software Development and Sustained Document Management Anyone involved in software development work knows

What is DTx (Digital Therapeutics)? DTx (Digital Therapeutics): A New Paradigm in Software-Driven Healthcare Digital technology has become pervasive in

Why Integration Testing is Essential: The Rationale Against Big Bang Testing In the development of medical devices and pharmaceutical software,

What is Traceability in the V-Model? The V-Model and Traceability: Effectiveness and Key Points for Implementation Are you familiar with

Hazard Source Separation in Software Design─Why Prioritizing Safety is Essential Introduction When working as an engineer, the most paramount priority