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  • Medical Standards for FPGA - The Elsmar Cove Quality Forum
    We are currently developing a safety critical medical device It has a power management board which has an FPGA to detect the supply rail voltages The FPGA we are planning to use is standalone and is Purley based on RTL Please clarify the following questions 1 Is IEC 62304 applicable for
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    Hi, I have a question concerning the 62304 classification (A,B and C) and the Software Detailed Design(SDS) of clause 5 4 of IEC 62304, so this would be for EUROPE For example, If I have 5 Software items that are class A and 1 Software item that is a class B, clause 5 4 1 specifies that the
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    Hello everyone, I have been tasked with conducting an internal review of one of the medical devices we make to bring it into IEC62304 compliance We are treating it as legacy software, with Class A software safety Section 4 4 3c) states software system test records are required to be
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    Hello, In chapter 5 1 4 of IEC 62304 , it is said that software development methods must be referenced This term is quite fuzzy for me I did not find any example Does it means , for example, Object Oriented Programming ? Thanks
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    Forums Medical Devices, Medical Information Technology, Medical Software and Health Informatics Medical Device Related Standards IEC 62304 - Medical Device Software Life Cycle Processes
  • Unit Test Documentation Requirements under FDA and IEC 62304 – What’s . . .
    Hello everyone, I’m looking for some clarification on unit test documentation requirements for medical device software under both FDA expectations and IEC 62304 compliance Specifically: • Does IEC 62304 explicitly require unit test reports to be retained as part of objective evidence, or is
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    Forums Medical Devices, Medical Information Technology, Medical Software and Health Informatics Medical Device Related Standards IEC 62304 - Medical Device Software Life Cycle Processes
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  • 62304 clause 5. 1. 1 Processes - The Elsmar Cove Quality Forum
    5 1 1 a) the PROCESSES to be used in the development of the SOFTWARE SYSTEM (see Note 4); NOTE 4 The software development plan can reference existing PROCESSES or define new ones When filling out a checklist audit for compliance with 62304, what are concrete examples of what is meant by
  • PEMS Documentation for Medical Device Software - Requirements
    Hello, For one of our medical device we are having two software's, one is pc based software which is used to view the measurements and another which is the firmware for the device My doubt is whether we need to follow PEMS documentation as per IEC 62304 for both the software for





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