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.…
A Comprehensive Guide to ISO 9626: Stainless Steel Tubing for Medical Use
ISO 9626 is a critical international standard that specifies the requirements and test methods for stainless steel tubing used in…
Understanding the Predetermined Change Control Plan (PCCP) in Regulatory Compliance
In the ever-evolving landscape of regulatory compliance for medical devices, software as a medical device (SaMD), and pharmaceuticals, the concept…
Understanding IEC 81001-5-1: Cybersecurity for Health Software
In today’s rapidly evolving digital healthcare environment, ensuring cybersecurity for health software and IT systems is paramount; one of the…
Biological Risk Assessment for Medical Devices
The biological risk assessment (BRA) is a crucial component in ensuring the safety of medical devices that come into direct…
Software Bill of Materials (SBOM)
The Software Bill of Materials (SBOM) has emerged as a fundamental requirement for managing third-party and open-source software components, especially…
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…
