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FDA released a draft guidance document for patient matched guides for orthopedic implants.  The guidance provides recommendations to manufacturers regarding the design-and-production process for these types of devices.  Patient matched guides, as the name implies, are unique to the patient and are created to assist pre-surgical planning.  The clinician is better able to visualize proper...
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This March 2022 Standards Navigator Report 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, our report keeps you...
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This September 2021 Standards Navigator Report 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, our report keeps you...
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This July 2021 Standards Navigator Report 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, our report keeps you...
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This January 2021 Standards Navigator Report 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...
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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:  Swedish objection to ISO13485 Harmonization
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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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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

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Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

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2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

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Next public offering: March 7 & 28, 2024

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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