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.…
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.…
