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Software in Medical Devices – Update

We have previously written about various aspects of the software development process, especially, the verification and validation activities in implanted and invasive medical devices.

Here is  an update on what is happening in the regulatory arena and how the regulatory groups are checking up on what we are doing.

Software Recalls 2012

The estimate for software recalls by the FDA for 2012 is 173. The software recalls for 2011 were 177 and for 2010 were 76. So far there are quite a few software recalls in 2013.

There are a number of new guidances and standards released and soon to be released – it’s worth getting up to speed if you are developing software for medical devices and concerned about reliability and software security:

  1. 21 CFR 880.6310, Medical Device Data Systems, FDA – released. This standard relates to hardware or software products that transfer, store,convert formats, and display medical device data. This application can be defined as a medical device which is a Class I device instead of the classification of your system. It has been used by a number of companies to define gateways between systems.
  2. ISO 82304-1, Healthcare Software Systems – Part 1: General Requirements For Product Safety – to be released maybe later this year. There is a draft copy out. This relates to medical devices that are only software. 
  3. MEDDEV 2.1/16, January 2012 – Guidelines on the qualification and classification of standalone software used in healthcare within the Regulatory framework of medical devices 4) ISO/IEC TIR 80002-1:2009, Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software – refers to the risk analysis on the software. This is an interesting aspect as we tend to analyze the risks on a system level.  If you have any questions please contact us. 
  4. ISO/IEC TR 80002-02, Medical device software – Part 2: Validation of software for regulated processes – to be released maybe later this year. This refers to software used in the all other aspects in the organization. 
  5. IEC 80001-1:2010, Application of Risk Management for IT Network incorporating Medical Devices – This is the risk management doctrine for hospitals, etc. employing medical devices on the network. If you supply your system to a hospital, you may be requested to let the hospital know if you are 8001 compliant. Once we know more on this, we’ll update you. 
  6. AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software – This is a technical report from the AAMI on the use of Agile in the software development.
  7. AAMI/ANSI SW87:2012, Application of Quality Management System concepts to Medical Device Data Systems (MDDS) – provides guidance for Application of Quality Management System concepts to Medical Device Data Systems (MDDS) 
  8.  AAMI TIR on Guidance on Health Software Safety and Assurance – future release
  9.  AAMI TIR on Classification of defects contributing to unacceptable risk in health software – future release

Click here to download the full article on FDA standards and guidance and software in medical devices  Software Update 020613

Courtesy of my colleague Mike Zeevi

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