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This December 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...
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This September 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...
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This July 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Recent standards and regulatory activity overview Medical device software Following the failure of the DIS of 62304 to be approved, the IEC 62304 working group requested input from the ISO and IEC member countries. There was not a consensus...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Standards and regulatory activity overview Medical device software It appears that in response to a question posed by the IEC 62304 working group, the ISO and IEC member countries want ISO 14971 to be required for use of the second...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Questionnaire asking the national bodies to choose which approach to risk management should be used in the second edition of IEC 62304. 62304 Edition 2 Questionnaire
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Standards and regulatory activity overview Medical device software Two webinars were held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health informatics, as well as the Member Bodies of ISO/TC 210, Quality management and...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Standards and Regulatory Activity Overview Medical device software Two webinars will be held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health informatics, as well as the Member Bodies of ISO/TC 210, Quality management...
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Here is the report for June/July, 2018. SoftwareCPRStandardsNavigatorReportfor2018-07
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This document provides Sherman Eagle's June 2017 standards status update to be used with the Standards Landscape document. It provides a summary of status updates to primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards.
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This content is only available to Standards Navigator and Standards Navigators PLUS subscribers.  See our Subscribe page for information on subscriptions. This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how...
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This document is the result of an industry-led initiative of the European Commission. It is targeted at app developers and its purpose is to foster justified trust among users of mHealth apps which process personal data. Standards Navigator Draft Health Code of Conduct
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/docs/scpred/standardsnavigator/SoftwareCPRStandardsNavigatorReport2015-1.pdf
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/docs/scpred/StandardsNavigator/SoftwareCPRStandardsNavigatorReport2014-11.pdf
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This content is only available to our Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. Read the Swedish formal objection to the harmonization of ISO 13485. Sweden Formal Objection ISO13485 Medical Devices
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This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The Industry response to the Swedish objection to ISO 13485 can be found at the following link:   Industryresponseto13485objection I had previously posted regarding the Swedish objection at this link:  
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This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The link provides the formal objection to the harmonization of ISO 14971 from the European Commission.   EN Deharmonization of Cen-Standards 2010-11
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This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The link provides the response from ISO TC 210 to the EC objections to ISO 14971.  ISO TC210 Comments on deharmonization of EN14971
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A new work item and draft technical report for guidance in implementing IEC 80001-1:2010. This TR provides practical guidance for doing risk management for hospital networks.The report is at the link provided until the review period ends on 24-Feb-2011. IEC...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A new work item and draft technical report for guidance in implementing IEC 80001-1:2010. This TR provides a framework for a dialogue between a medical device manufacturer and a hospital regarding system and data security controls. The report is at...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A new work item and draft technical report for guidance in implementing IEC 80001-1:2010. This TR provides guidance for considering risk when using wireless communications in a hospital.  The report is at the link provided until the review period ends...
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The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304.
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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