ISO 9626: Understanding Its Importance in Medical Applications
ISO 9626 is a critical international standard that specifies the requirements and test methods for stainless steel tubing used in…
Hemocompatibility of Medical Devices: an Overview
Hemocompatibility is on of the test requested to assess the safety of a medical devices that come in contact with…
Product Life Cycle for Medical Devices
The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and…
IEC 60601 – Overview of the Main Requirements
The IEC 60601 has played and still currently plays a key role for safety of active medical devices. The IEC…
Software Architecture according to IEC 62304
In this article we will go through the requirements associated to Software Architecture according to IEC 62304:2006/AMD-1:2015. The IEC 62304…
Design Transfer: A practical Approach
In the framework of the process of Design and Development, the design transfer (DT) corresponds to the last phase, where…
Design and Development Plan
In this article, we want to give you a deep dive into the requirements associated to the Design and Development…
Design Verification vs Design Validation: What are The Differences?
Introduction to Verification vs Validation Design verification and validation are critical components of the design process when developing a medical…
ISO 62366 and Usability Requirements for Medical Device
ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to…
Design History File (DHF): An Overview
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation…