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This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. Raffaele Caliri and Jordan Pate have recently updated our 62366-1 Assessment Checklist to align with the 2020 amendment.  This version of the standard has been pared down a bit and looks a lot different than the familiar 2008 version...
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This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions. What is a Real-Time PMA Supplement? Section 737(4)(D) of the Federal Food, Drug, and Cosmetic Act defines a Real-Time PMA Supplement as: “a supplement to an approved premarket application or premarket report under section 515 that requests a...
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This 62304 Conformance Checklist Tool is only available to Premium and higher subscribers.  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 created specifically for this type of software - it was not...
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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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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Use this as a starting point to gather information on the software development environment (and related information) as required in FDA's Guidance for Software Information to be included in open market submissions. It is only intended as a starting...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR checklist for "IEC 82304-1: Health software - Part 1: General requirements for product safety."  Download: IEC 82304 SoftwareCPR Checklist SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device...
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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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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. A sample checklist for releasing or updating software is at the link provided. GoLiveiChecklistTrainingExample111115   . . . Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best...
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This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. In SoftwareCPR training classes on IEC 62304 and FDA regulation, we sometimes use a fabricated example of a vertical slice of software documentation. This example includes requirements specification, risk analysis, design, and testing along with commentary for one functional...
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The document at the link provided is a short checklist for helping ensure or assess requirements quality. It is an educational aid to be used only by knowledgeable individuals and should not be used blindly or considered comprehensive. This was prepared by Brian Pate with input from Alan Kusinitz. RequirementQualityChecklist  
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Mary Decareau of SoftwareCPR prepared a tiered checklist for EN 62366 Medical devices – Application of usability engineering to medical devices for our internal use and we are making it available to paid subscribers at the link provided and...
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Risk/hazard analysis for medical devices and their software require extensive analysis, documentation, and maintenance of complex information. Creation and maintenance of extensive tables, fault tree, and HAZOP diagrams can seem overwhelming. For complex and high risk systems the information can be voluminous and software tools can be very productive. Trace tools such as DOORS, CALIBER-RM,...
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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 a training template used in SoftwareCPR training on production and quality system software validation. It presents a general validation form for discussion that can be used itself for simple applications or tools...
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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. Slides from a 2010 presentation by Molly Ray of SoftwareCPR are at the link provided as a pdf. These slides provide an introduction to pre-market submissions for devices that are, or contain, software. SoftwareCPRPresentation-510ks-101510
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The slides from a SoftwareCPR presentation on compliant use of Agile Methods for medical device software development is at the link provided. This was prepared and presented by Brian Pate and Mike Russell and similar slides are used in SoftwareCPR’s public courses. SCPRed_AgileForMedicalDevices-SoftwareCPRpresentation101010
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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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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf is a SoftwareCPR training aide and should not be used blindly to fill in the blanks. It is a partial example of a software risk analysis procedure and report. It is just one partial approach that...
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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 a set of FDA reference documents and partial examples used in SoftwareCPR training courses on Validation of Production and Quality System Software and Part 11. This is just a partial set and...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf is a training aide and should not be used blindly to fill in the blanks. It is a partial example of Software Design Specification tailored from an IEEE standard. Design Spec - SoftwareCPR Template-Rev3
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf is a training aide and should not be used blindly to fill in the blanks. It is a partial example of a User Interface Design Specification. UI Design - SoftwareCPR Template-Rev2
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf is a SoftwareCPR training aide and should not be used blindly to fill in the blanks. It is a partial example for a software requirements specification (SRS) for a small surgical device. SRS-template-embeddev-SoftwareCPRtrainingdocRev2 . . ....
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed.  This example is modeled on the approach required by ISO 14971 and expands on it with...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. This reference manual includes select FDA documents as well as SoftwareCPR training aides and checklists that SoftwareCPR uses in its training courses on Validation of Clinical Trials Computer Systems. The PDF is over 2 MB so be patient downloading...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. This reference manual includes the following documents in a single pdf with bookmarks and a clickable TOC. Be sure to click bookmarks in adobe so you can jump around the document easily. This pdf contains key FDA software guidances...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR has prepared an audit checklist for assessing compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures regulation.  The checklist is intended for use by expert assessors knowledgeable in the regulation, its preamble, history, and current enforcement...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aide on Part 11. It provides information and explanation of the Feb 2003 FDA redirection of its Part 11 regulation. It includes a summary of the areas of Part...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. A one page memory jogger for key sections of the Part 11 rule is at the link provided.  This is a SoftwareCPR training and auditing aide. This was updated Feb 2003 to highlight items for which FDA is changing...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aid that provides a partial template with some tips for construction of a handbook/procedure that addresses IT/Network issues regulatory compliance with 21 CFR Part 11 requirements and to support...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 21 CFR Part 11 Electronic Records and Electronic Signatures is a short rule with a lengthy and informative preamble.  The attached training aid provides section of the rule side by side with relevant excerpts of the preamble with some...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached document is a SoftwareCPR training aid with commentary and explanation of 21 CFR Part 11 Electronic Records; Electronic Signatures by SoftwareCPR.  Note the date of this document as this is an evolving area. erecordsesigscommentary09012000-346
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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.

Instructor: Brian Pate

Next public offering:  TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

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!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

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

Instructors: Mike Russell, Ron Baerg

Next public offering: TBD

 


 

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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