Updates

Software in Medical Devices – Update for Q1/Q2 2024 The past year, as in previous years, life has not been easy for many reasons. According to an EY report, equity investment in medical device companies fell to its lowest point in seven years, declining 27% to $13.8 billion. We have finally seen the FDA moving forward with new standards. The MDR/IVDR is still happening but is moving slowly.  There is a major backup in getting to the notified body. This is a continuation of the software updates I have been sending out. Please check out all the references to download…

Software in Medical Devices – Update for Q3/Q4 2023 The past year, as in previous years, life has not been that easy from many distinct aspects. We have finally seen the FDA moving forwards with new standards. The MDR is still happening but moving slowly as there is a major backup in getting to the notified body. 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…

Software in Medical Devices – Update for Q1/Q2 2023 The past year, as in previous years, life has not been that easy from many distinct aspects. We have finally seen the FDA moving forwards with new standards. The MDR is still happening but moving slowly as there is a major backup in getting to the notified body. 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…

Software in Medical Devices – Update for Q3/Q4 2022 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. 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 exceptionally large. The is an emphasis on “digital health” where the FDA is fast-tracking many devices (even…

Software in Medical Devices – Update for Q1/Q2 2022 The past year has been exceedingly difficult for all of us, from many distinct aspects. Not much has been happening in releasing new standards and the MDR has finally happened. 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…

Software in Medical Devices – Update for Q3/Q4 2021 The past year has been exceedingly difficult for all of us, from many distinct aspects. Not much has been happening in releasing new standards and the MDR has finally happened. 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…