ISO 42001 Certification Process
In an era defined by rapid advancements in artificial intelligence (AI), organizations face growing pressure to ensure that AI systems…
Understanding Medical Device Software Standards: Ensuring Safety and Efficacy in Healthcare
In the realm of healthcare, medical devices play a pivotal role in diagnosing, monitoring, and treating various medical conditions and…
ISO 14937: Overview of the main Requirements
ISO 14937, titled “Sterilization of Health Care Products — General Requirements for Characterization of a Sterilizing Agent and the Development,…
Patch Management for Medical Device: an Overview
In the realm of medical devices, software is not just an enabler but often a lifeline. Patch management for medical…
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…
Medical Device Cybersecurity Testing
Cybersecurity nowadays play a fundamental role for connected device and cybersecurity testing became of essential importance to ensure quality, safety…
MDCG 2022-21: Requirements for Preparation of the Periodic Safety Update Reports
The long awaited MDCG 2022-21 has been finally published and preparation of the Periodic Safety Update Report became much easier.…
ISO 11138 Family of Standards: Requirements for Biological Indicators
ISO 11138 is a crucial standard in the field of sterilization, specifically focusing on the validation of sterilization processes for…
Cybersecurity Risk Assessment
In an era dominated by digital transformation and interconnected systems, cybersecurity risk assessment is more critical than ever. Organizations across…
ISO 80369-1: An Essential Guideline to reach Compliance
ISO 80369-1 entitled “Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements” specifies the design,…
