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62304
COURSE DATES: June 4 – 6, 2019 TRAINING LOCATION: Boston, MA USA COST: 3 Full Days for $2,495.00 Limited number of “Early Bird” Discounted seats:  $1,795.00 Registration link Only a limited number of discounted seats are available.  For more information on the course, use the form below. This three-day course provides a clear understanding of...
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What does one need to know about IEC 62304? In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience.  The topics we plan to cover in our 2019 course are below. Topics: Regulatory...
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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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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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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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A committee draft for vote of “IEC 62304 Ed 2: Health Software – Software life cycle processes” has been circulated for ballot. Edition 2 expands the scope of IEC 62304 to include health software that is not regulated as a medical device, and the title has been changed accordingly. This will be the last opportunity...
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Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Created a job aide which compares the IEC 62304 and IEC 82304 elements for requirements. This is only intended to be used as a starting point and requires interpretation based on knowledge of each standard and the type of...
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The link provided is our revised checklist for changes in Amendment 1. You will need to login as a paid subscriber to download this checklist.
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains a training aid that provides an overview comparison between the 2015 Amendment of IEC 62304 and FDA requirements based on 62304 Safety Classes. SCPRed_SoftwareCPR-FDA-62304SafetyClasscomparisonTrainingAide
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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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In SoftwareCPR training classes on IEC 62304 and FDA regulation we sometiems use a fabricated exmple of a vertical slice of software documentation. This example includes requirements specification, risk annalysis, design and testing along with commentary for one functional area. The document at the link provided provides this using the calibration portion of an in-vitro...
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This document provides answers to questions that have been asked to notified bodies regarding using EN 62304 for regulatory purposes in the EU. FAQ 62304
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IEC SC 62A has agreed that the 2nd edition of 62304 will be expanded to cover all Health Software, not just medical devices. In the interim, an amendment will be issued to clarify current safety classification as well as application of 62304 for legacy software (this was originally intended to be done as part of...
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The first committee draft of the second edition of “IEC 62304 Medical device software life cycle processes” has been circulated internally for comment. Major changes include a revision of how software safety class is determined, which could reduce the tendency towards most software being Class C; clear requirements for legacy software that explain how conformance...
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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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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The pdf at the link provided contains selected templates used in SoftwareCPR training on medical device software standards focused on IEC 62304. These are not intended to be ideal for all situations or comprehensive but are intended to serve...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached zip file contains 3 training templates. One is for an example software development SOP, one is a companion software development plan, and one is a template for software risk analysis incorporating the concept of predefined categories of...
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