Updates

Software in Medical Devices – Update for Q1/Q2 2019 This is a continuation of the software updates I have been sending out. Please check out all the references to download and/or to purchase. If you have any questions, please contact us. Software is everywhere in medical devices and IVDs. The FDA and CE are becoming more pedantic on how they review and relate to software. The number of companies getting into the field is growing and the amount of software being developed for medical is very large. The is an emphasis on “digital health” where the FDA is fast-tracking many…

Software in Medical Devices – Update for Q3/Q4 2018 This is a continuation of the software updates I have been sending out. Please check out all the references to download and/or to purchase. If you have any questions, please contact us. Software is everywhere in medical devices and IVDs. The FDA and CE are becoming more pedantic on how they review and relate to software. The number of companies getting into the field is growing and the amount of software being developed for medical is very large. The is an emphasis on “digital health” where the FDA is fast-tracking many…

Software in Medical Devices – Update for Q1/Q2 2018  This is a continuation of the software updates I have been sending out.  Please check out all the references to download and/or to purchase. If you have any questions, please contact us. Software is everywhere in medical devices and IVDs. The FDA and CE are becoming more pedantic on how they review and relate to software. The number of companies getting into the field is growing and the amount of software being developed for medical is very large. Software Recalls Q1-Q2 /2018 We have been following the recalls and there were…

Software in Medical Devices – Update for Q3/Q4 2017  This is a continuation of the software updates I have been sending out.  Please check out all the references to download and/or to purchase. If you have any questions, please contact us. Software is everywhere in medical devices and IVDs. The FDA and CE are becoming more pedantic on how they review and relate to software. The number of companies getting into the field is growing and the amount of software being developed for medical is very large. Software Recalls Q3-Q4 /2017 We have been following the recalls and there were…

Software in Medical Devices – Update for Q1/Q2 2017  This is a continuation of the software updates I have been sending out.  Please check out all of the references to download and/or to purchase. If you have any questions, please contact us. FDA Responses to 510K - Software Numerous companies have received generic responses from the FDA concerning their software testing (what we would call unit and integration testing).  The wording received from the FDA in all of the cases is shown below: The submission did not include information on the tools, such as static analysis tools, that you used…

Software in Medical Devices – Update for Q3/Q4 2016  This is a continuation of the software updates I have been sending out.  Please check out all of the references to download and/or to purchase. If you have any questions, please contact us. Software Recalls Q3-Q4 /2016 We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly as listed on the FDA website. There were almost 60 recalls in this quarter relating to software, including 3…

Software in Medical Devices – Update for Q1 & Q2 2016  This is a continuation of the software updates I have been sending out.  Please check out all of the references to download and/or to purchase. Software Recalls Q1 and Q2/2016 We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly as listed on the FDA website. There were almost 60 recalls in this quarter relating to software, including 3 class I recalls. There may…

Software in Medical Devices – Update January 31, 2016 This is a continuation of the software updates I have been sending out.  Please check out all of the references to download and/or to purchase. Software Recalls Q2, Q3 and Q4/2015 We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly. There were over 150 recalls in these quarters relating to software, including 5 class I recalls. Brainlab Cranial Image-Guided Surgery (IGS) System, Class I -…

Software in Medical Devices – Update This is a continuation of the software updates I have been sending out.  Please check out all of the references to download and/or to purchase. Software Recalls Q1/2015 We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly: Hospira Plum A+,Plum A+3 Infusion Systems, Class I - The infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound…

Software in Medical Devices – Update This is a continuation of the software updates I have been sending out. Please check out all of the references to download and/or to purchase. Software Recalls 2014/2015 Last update we noted the FDA report and recalls for the end of 2014/beginning of 2015. We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly: Covidien Puritan Bennett 980 Ventilator, Class I - A software issue may lead to ventilator…