ISO 10993-18: A Comprehensive Guide to Chemical Characterization of Medical Devices
ISO 10993-18 is a critical standard for evaluating the biological safety of medical devices through chemical characterization. This standard defines…
IEC 80001-1 : Overview of the Main Requirements
In today’s rapidly evolving healthcare environment, the integration of medical devices into IT networks has become both an essential necessity…
ISO 10993-6 and Implantable Medical Devices
ISO 10993-6 is a crucial part of the ISO 10993 series, which focuses on the biological evaluation of medical devices.…
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…
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…
ISO 10555-1:2023 – Requirements for Intravascular Catethers
ISO 10555-1 is part of the ISO 10555 series, which specifies requirements for intravascular catheters, devices commonly used in medical…
Cybersecurity Risk Assessment
In an era dominated by digital transformation and interconnected systems, cybersecurity risk assessment is more critical than ever. Organizations across…
