By

Alan Kusinitz
Seapine Software (seapine.com) which provides a variety of development tools published its 2014 report on the state of software development for medical devices. This report was generated based on input from 500 individuals in the medical device industry. It contains a breakdown of risk management methods used, key documentation challenges, requirements management approaches used, test...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdf
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdf
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Sherman Eagles of SoftwareCPR® provides the following summary of some key points from FDA’s webinar on their premarket cybersecurity guidance on October 29. In the webinar FDA noted that the Instructions for Use should include what cybersecurity controls are needed in the use environment, but stated that it is not sufficient for a device to...
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The FDA held a two day public workshop on Collaborative Approaches for Medical Device and Healthcare Cybersecurity on October 21-22. Documentation on the workshop including the video recording of the workshop can be found at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm412979.htm.
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/docs/scpred/SoftwareCPRenhanced-V-Diagram1014.png
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM419468.pdf
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM419468.pdf
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Brian Pate of SoftwareCPR suggest that a good rule of thumb is: If differences in the final product, produced by two different development groups using the same specification element, resulted in unacceptable differences in safety or efficacy then it would likely be a “requirement”. Otherwise it is most likely to be a design specification. This...
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http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm370879.htm
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418469.pdf
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418205.pdf
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http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf
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Brian Pate and Alan Kusinitz of SoftwareCPR.com will be instructing next week’s (9/29-9/30/14) course with FDA instructors and another industry instructor. Compliant Use of Agile Practices in the Development of Medical Device Software Course: September 29-30, 2014 Arlington, VA This course focuses on compliant use of Agile Methods in medical device software development using AAMI...
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The IMDRF issued “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.” This guidance provides terminology and possible framework for the industry and regulators to work from in discussing and dealing with risk related to standalone software used as a medical device.
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http://www.fda.gov/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT/
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The link provided is to FDA’s relatively new webpage related to connected health, including cybersecurity, Health IT, Mobile Medical Apps (MMA), and wireless medical devices. The MMA page provides lists of examples of types of MMApps and how they are or are not regulated. https://www.fda.gov/medicaldevices/digitalhealth/
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http://www.fda.gov/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT/
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/docs/FDADraft510kexemptionsguidanceAug2014.pdf
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/docs/FDAFiscalYear2015userFeeRates.pdf
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/docs/FDAFiscalYear2015userFeeRates.pdf
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/docs/FDAEvaluatingSubstantialEquivalenceGuidance0714.pdf
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http://www.advisory.com/Daily-Briefing/2014/07/16/Google-wants-a-piece-of-the-eye-teams-up-with-Novartis-on-smart-contact-lenses
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FDA issued a draft guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. This draft exercises FDA enforcement discretion to essentially deregulate MDDS and Imaging Storage and Coummincation systems despite their classifcation rules. The guidance is at the link provided and proposes the new policy and provides specific wording changes...
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http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-encourages-medical-device-data-system-innovation/
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A number of draft standards were released for comment, including including several related to specific security for medical devices and Health IT: AAMI TIR38 – AAMI Medical device safety assurance case guidance IEC Health SW Standards Framework ISO 27799 Health informatics “Information management in health using ISO/IEC 27002” IEC TR 80001-2-8, Application of risk management...
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Just a reminder that FDA maintains a blog at the link provided. This generally contains short announcements with some explanation from FDA leads on policy and specific projects across all FDA divisions although one select specific divisions using the categories options. One recent posting was from Bakul Patel of the device center regarding the recent...
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In SoftwareCPR’s experience, translations and localization of user interfaces and labeling of medical devices for distribution in a variety of geographic regions can be challenging and can present safety issues if not properly handled.  Alan Kusinitz of SoftwareCPR® co-authored an article on localization risk management with one of the large companies that provides such services...
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It appears that the Center directed ORA to inspect Class I firms and provided each regional/district offices with a list of 50 firms to choose from. These inspectionsappear to be in part a validation exercise of the risk based approach to only inspecting higher risk firms. We are assuming it is for the remainder of...
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http://www.fda.gov/downloads/Training/CDRHLearn/UCM311629.pdf
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ECRI Institute published its Top 10 Patient Safety Concerns for Healthcare Organizations to give healthcare organizations a gauge to check their track record in patient safety. The list originally appeared in its Healthcare Risk Control (HRC) System newsletter, the Risk Management Reporter, and is reprinted in this report. The list is partly based on more...
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This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. Green Paper on Mobile Health
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The following draft standards are being circulated for comment or ballot. More information is availale to Standards Navigator Subscribers in the the Standards Navigator topic:-IEC 62304 Amendment CDV -$ISO 16142-1 DIS -ISO 90003 FDIS -ISO 15289 FDIS -ISO 24748-4 DIS -ISO 24748-6 NP
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This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. BSI WP EU Regulations
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Alan Kusinitz Managing Partner of SoftwareCPR accepted appointment to the Biomedical Instrumnetation and Technology journal editorial board. Alan authored a number of articles for this journal and performed peer revieiws for the journal over the years.
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Lucille Ferus a Partner at SoftwareCPR provided training to the Tawian FDA on US and international medical device software regulation in April. We continue to see increased focus on software regulation in countries outside the US..
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SaMD. Standalone Medical Devices. Do you have SaMD or software systems that might be classified as medical devices, even if FDA has chosen not to regulate them? Do you know the features that might trigger medical device classification? Whether regulated or not, a well developed and sufficiently documented risk analysis and management plan is essential...
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