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standards

Standards

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 62304 Conformance Checklist Tool is typically only available to Premium and higher subscribers, but is being made available to all on our website.  See our Subscribe page for information on subscriptions. 62304 can provide an excellent framework from which to design a software process for medical device, medical mobile app, and/or HealthIT software.  62304 was...
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The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today.  The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the...
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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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On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software.  The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies.  This standard is lengthy and technical in terms of its approach to defect...
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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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One of the most difficult challenges for medical device and HealthIT manufacturers is to properly "level" the design requirements for their medical device systems such that it is clear when it comes to design validation versus design verification.
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Certainly everyone with any connection to information technology and networked devices is concerned with cybersecurity. However, often we just miss the basics – we do not practice good cyber hygiene. While not intended to be comprehensive or state-of-the-art, here are some security basics (or as some call it, “cyber hygiene”) that one should consider when developing...
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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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Underwriters Laboratories, Inc. published the First Edition of the Standard for Safety for Remote Software Updates, UL 5500 on September 6, 2018. This standard covers remote software updates, accounting for the manufacturer’s recommended process to ensure safety. It is limited to software elements having an influence on safety and compliance with the particular end product...
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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 and corresponding general aspects for medical devices. These webinars are being held to explain the status of the IEC 62304 project. A committee...
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UL 5500 – Safety for Remote Software Updates has been adopted as a U.S. National Standard. It covers the remote updating of software via the manufacturer’s recommended process. It is limited to software elements having an influence on safety and on compliance with the particular end product safety standard. It is not specific for medical...
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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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Prepared a visual aide (one of many we use in our training courses) of key Medical Devices Standards and FDA guidance related to software.  Enjoy! SoftwareCPR Sw Stds Guidances
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This update addresses International and US National medical device standards ("a view of the landscape") being developed or revised that may be of interest to developers of software for medical devices or healthcare. Some of these standards are used directly for regulatory purposes and others may be valuable in demonstrating to regulatory authorities that a...
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The International Medical Device Forum, which FDA participates in, released a draft for comment entitled, “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.“  This guidance document describes fundamental design and manufacturing requirements, referred to as “Essential Principles of Safety and Performance” that, when met, indicate a medical device is safe and...
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Summary of primary medical device standards as well as standards specific to Medical Device and Health IT software
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"AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems" available for purchase
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The FDA published a list of standards added to their recognition list on August 21, 2017. IEC 82304-1 Edition 1.0 2016-10. Health software part 1: General requirements for product safety are included on this list in the Software/Informatics Section, along with a number of other standards related to device communication (including specifics of glucose meters...
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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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“IEC TR 80002-2 Medical device software – Part 2: Validation of software for medical device quality systems” has been published. This TR provides guidance for new requirements in ISO 13485:2016 for validating software used in quality systems. ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labeling, packaging, distribution and...
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AAMI Software and IT-related standards working groups include one for interoperability (with 3 standards work items), one for Device Security (with 2 standards work items), one for Wireless, one for SW Defect Classification, and one for AAMI/UL 2800-1 for specification of architecture independent requirements. There is also a separate Health IT Committee with several items...
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Although IEC 82304-1 Health Software: General requirements for safety has been published it is not clear when it will be harmonized in the EU. Nonetheless it appears EU notified bodies are treating it as “state-of-the-art” and are likely to expect it to be used for software products that are regulated as medical devices. IEC TR...
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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 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 the standards will impact the development of medical device and Health IT software. This is truly a MUST READ...
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“IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved and released. It can be purchased from the ISO at the link provided. This standard addresses Health Software Products in general and does not attempt to define which are regulated and which are not. Its scope is all standalone software...
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A final draft (FDIS) of “IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved. The standard will be published after final editing. This is expected around the end of the year (2016). The primary focus of this standard is on requirements for the developers of the software product. It...
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A final draft for approval (FDIS) of “IEC 82304-1: Health software – Part 1: General requirements for product safety” has been circulated. The ballot ends on October 14, and the standard is expected to be published by the end of 2016. This standard applies to software products that do not require specific hardware designed for...
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The purpose of DTSec is to establish a standard used to provide a high level of assurance that electronic products for the treatment of diabetes deliver the security protections claimed by their developers and required by their users. Diabetes Tech Society Standard
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http://www.gpo.gov/fdsys/pkg/FR-2016-04-04/html/2016-07467.htm
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Click here to view a summary of my highlights and rationale, along with some practical implementation tips for the new ISO 13485:2016:  SoftwareCPR-ISO13485 revision March 2016 highlights Some of the revisions add items included in FDA’s 21 CFR 820 Quality System Regulation such as Design Transfer, Validation of automation of quality system activities, detailed records, and...
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The Final Draft International Standard was approved at the end of 2015 and will be submitted for publication. The standard is expected to be published by the end of March 2016.  A three year transition period has been proposed.
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Sherman Eagles of SoftwareCPR expects increased standards and regulatory activity related to Software and HealthIT in 2016. Here are some of the areas to watch: IEC 82304-1 Health Software: General requirements for safety will be completed during the first half of 2016. It is intended that this standard be harmonized in the EU, but it...
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In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for legacy software and clarifications to the use of risk in safety classification, keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: Reduction in the exemptions...
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A committee draft for vote has been circulated for the AAMI TIR 57 Principles for medical device information security risk management. The objective of this TIR is to provide guidance on how medical device manufacturers can manage risks from security threats that could impact the confidentiality, integrity, and/or availability of the device or the information...
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The National Institute of Science of Technology issued Version 1 of its framework for improving cybersecurity for critical infrastructure including health care. The full press release is at the link provided.
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The first amendment to IEC 62304 amendment has been published as Edition 1.1. You can purchase just the amendment, which notates what has changed, or a consolidated redline version. It is currently available from ANSI or IEC. AAMI will publish it in the near future, although it may be expensive to purchase from AAMI. This amendment mainly focuses...
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The National Electrical Manufacturers Association (NEMA) has published a guidance document on supply chain best practices for electrical equipment and medical imaging manufacturers to minimize the possibility that bugs, malware, viruses, or other exploits can be used to negatively impact product operation. The document is a representation of identified best practices that vendors can implement...
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The CWE can be a useful reference to use when performing medical device software risk management and security vulnerability analysis. The Common Weakness Enumeration Specification (CWE) provides a common language of discourse for discussing, finding and dealing with the causes of software security vulnerabilities as they are found in code, design, or system architecture. Each...
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The ballot on the final draft of the IEC 62304 amendment, which focuses on safety classification and legacy software, closes in May. We expect publication by July, followed by a consolidated version that incorporates the amendment. Adoption by CENELEC as an EN is happening concurrently, so harmonization by the EU should happen late this year...
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ANSI/AAMI/IEC TIR80001-2-5:2014 “Application of risk management for IT-networks incorporating medical devices Part 2-5: Application guidance: Guidance on distributed alarm systems” has been published. Sherman Eagles of SoftwareCPR was a co-chair for this.
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/docs/scpred/standardsnavigator/SoftwareCPRStandardsNavigatorReport2015-1.pdf
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AAMI has filed a Project Initiation Notice with ANSI for a new standard on Application of Quality Management Principles and Practices to Health IT. The notice was published in the ANSI Standards Action publication on January 23. The notice is reproduced below. BSR/AAMI HIT2000-201x, Application of Quality Management Principles and Practices to Health IT Stakeholders:...
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A committee draft (CD) of “IEC TR 62366-2: Medical devices – Part 2: Guidance on the application of usability engineering to medical devices” was issued for comment. This technical report provides medical device manufacturers with guidance on how to integrate usability engineering (also called human factors engineering) principles and user interface design practices into their...
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/docs/scpred/StandardsNavigator/SoftwareCPRStandardsNavigatorReport2014-11.pdf
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AAMI TIR50: 2014 “Post-market surveillance of use error management” addresses use error detection for medical devices from the clinical, manufacturer, patient, user, and regulatory perspective. The goal is to provide guidance on how these individuals can best collect, assess, and leverage post-market use error data to mitigate product risk, and to improve product safety and...
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There is a new draft for vote of ISO 13485 Medical Devices – Quality Management systems – requirements for regulatory purposes. This version updates the references to ISO 9001 to the 2008 version. Some new requirements include: A requirement for a risk management process has been added in the product realization phase and ISO 14971...
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NIST received comments on the Preliminary Cybersecurity Framework for improving critical infrastructure cybersecurity and is updating the framework. They have announced that the final version (Version 1.0) will be released on February 13. When it is released, the Final Framework will be posted at NIST.
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The International Telecommunication Union (ITU) has adopted the Continua Design Guidelines (CDG) that contain specifications to ensure the interoperability of devices used for applications monitoring personal health (Recommendation ITU-T H.810 Interoperability design guidelines for personal health systems). ITU-T H.810 is available at the link provided: http://www.itu.int/rec/T-REC-H.810-201312-I
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