Hi Peter,
From the global perspective, there are standards and guidelines available.
At the top level, there is IEC 60601-1 (
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance). Clause 14 of this standard provides requirements for 'PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)'. One requirement in this Clause is for a 'PEMS DEVELOPMENT LIFE-CYCLE' to be documented, and it provides a cross reference to another standard: IEC 62304 (
Medical device software – Software life-cycle processes). Both of these standards are FDA-recognized and are also 'harmonized' European standards.
There is also a Part 2 particular standard for electrocardiographs, which is IEC 60101-2-51 (
Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs), although this makes no specific requirements for software. This standard is harmonized in Europe, but is not FDA-recognized.
Another standard cross referenced from these standards is ISO 14971 (
Medical devices – Application of risk management to medical devices), for which a guidance document exists for software in medical devices: IEC/TR 80002-1 (
Medical device software – Guidance on the application of ISO 14971 to medical device software). As guidance, this document is neither harmonized in Europe nor FDA recognized.
FDA has its own guidance documents on software issues, most notably:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
- Off-The-Shelf Software Use in Medical Devices
- Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Postmarket Management of Cybersecurity in Medical Devices
Hope this helps a little more.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com------------------------------
Original Message:
Sent: 08-Apr-2017 23:53
From: Anonymous Member
Subject: software validation of electrocardiographs with analytical function
This message was posted by a user wishing to remain anonymous
I believe there are some IEC or ISO standards that relate to this. Find some other products on the market that do this, identify their product codes, and then look up the product codes on the FDA website and it will list the standards
Original Message:
Sent: 08-Apr-2017 13:45
From: Glen Park
Subject: software validation of electrocardiographs with analytical function
I can speak to this from FDA perspective. There is a guidance: General Principles of Software Validation; Final Guidance for Industry and FDA Staff that addresses the principles for validating the software. You can find additional particulars from the 510k database on software that has been previously approved that evaluates such data as HR variability. As long as you are taking data provided from devices that are otherwise approved and only providing an answer that is subject to interpretation by a medical professional, it is pretty straightforward. The bigger challenge is clinical data that might be required to make claims.
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Glen Park
Scynexis, Inc.
Jersey City NJ
United States
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Original Message:
Sent: 07-Apr-2017 14:01
From: Peter Miko
Subject: software validation of electrocardiographs with analytical function
Dear Colleagues,
I need some help.
What rules (regulations, directives, guidelines and harmonised standards) apply on the software validation of electrocardiographs having analytical functions (e.g. calculating average of a few recorded cardiac cycles’s parts, like QT variability, QT dispersion)?
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
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