General safety requirements for electrical medical devices
No matter what kind of medical device you are working on, there are some general requirements related to safety which will apply to your medical device, or the development process of that device. This article will introduce the general safety requirements, as defined...
How to define IEC 60601 test plans and protocols for medical devices
This article will go over the process of writing test plans and protocols for medical devices in line with the IEC 60601 standard. These documents are essential in order to demonstrate that your medical device meets the established requirements. In the video below,...
How to identify and manage critical components
This article will help you in identifying and managing critical components. The term critical components is used to identify safety-related components in the test report form as required by clause 4.8 of the standard. Critical components are an important topic –you...
Developing an insulation diagram for electrical medical devices
The development of a good insulation diagram is an extremely useful practice as it helps you to define how your design meets the requirements of the IEC 60601-1 standard.To find out a few important things related to insulation diagrams, check out the short video...
How to integrate proactive safety by design with medical device risk management
Managing the integration of safety and risk management is a vital key to successful medical device development. Many of the requirements of the safety standards are verified by inspection of your risk management file. This article will introduce you to elements of...
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