SOUP Management according to ISO 62304
One key aspect of software lifecycle management under ISO 62304 is the handling of Software of Unknown Provenance (SOUP). SOUP…
Customer Property in ISO 13485: A Comprehensive Guide
One of the key aspects of this standard is the management of customer property, which is outlined in Clause 7.5.10.…
ISO 10993-7: Ensuring Safe Limits for Ethylene Oxide Residues
ISO 10993-7 plays a crucial role in ensuring the safety of medical devices sterilized using ethylene oxide (EO). This standard…
A HIPAA Violation Could Result In: Consequences and Examples
The Health Insurance Portability and Accountability Act (HIPAA) is a critical framework designed to protect patient data; do you know…
A Practical Guide to Understanding and Implementing HIPAA Law
The Health Insurance Portability and Accountability Act (HIPAA) is a foundational law in the U.S. healthcare system that governs the…
Privacy Impact Assessment
In an era where data privacy is both a legal mandate and a trust-building necessity, conducting a Privacy Impact Assessment…
ISO 27701 and Privacy Management System
In today’s data-driven world, protecting personal data is no longer optional; it is a regulatory and ethical imperative; the ISO…
ISO 27002: Enhancing Information Security Controls
In today’s interconnected digital landscape, organizations face a growing array of cybersecurity challenges and this is the framework where ISO…
The Future of Medical Device Interoperability: Aligning with FDA and MDCG Cybersecurity Requirements
In today’s rapidly advancing healthcare environment, medical device interoperability has become a cornerstone for effective and efficient patient care. Interoperability—the…
The AI Act: An Overview
Artificial intelligence (AI) is reshaping industries, economies, and societies across the globe. While AI offers enormous potential, it also brings…
