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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Crimson Life Sciences which performs language translations for labeling and user interfaces was assessed by Underwriters Laboratory for conformance with the ISO 14971 Medical Device Risk Management standard. The summary of the audit results is available at this link...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Our SoftwareCPR audit checklist for assessing conformance with the FDA Guidance for "Computerized Systems Used in Clinical Trials" can be viewed and downloaded at this link:  ClinicalTrialsSWFullChecklist. This checklist has been updated by Mary Decareau of SoftwareCPR to reflect...
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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 is a topic of current focus for FDA and industry. In February 2003 FDA announced a major change in direction regarding Part 11 and withdrew all previous draft Part 11 guidance and the Part 11...
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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 is a reprint of an article entitled "Uses and Misuses of Probability in Medical Device Risk Management" authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal...
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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 Level and higher subscribers.  See our Subscribe page for information on subscriptions. At a 1-day current regulatory topics session by ASQ held in Needham, MA, on June 16, 2005, Alan Kusinitz, Managing Partner of SoftwareCPR®, gave a presentation on the recent FDA Cybersecurity Guidance and the new revised FDA "Guidance...
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We hope you find this Regulatory Roadmap on HIPAA Privacy and Security useful.
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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 reprint of a chapter from an AABB book. The book is titled "Information Technology in Infusion Medicine".  The chapter is on 21 CFR Part 11 Electronic Records;Electronic Signatures and was authored by Alan Kusinitz,...
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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. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance and Part 11 Representative (John Murray) gave the first presentation on FDA's changes in its approach to Part 11.  The slides from this presentation can be...
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This content is only available to Premium Level or higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance Expert and AAMI Software Committee co-chair (John Murray) gave a presentation on FDA's software message and the role standards can play to benefit industry and...
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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. SoftwareCPR suggestions for a validation or Part 11 master plan are that it be a high-level plan not providing detailed document or protocol formats. Generally it is best if a master plan is a transient document.  It gets constructed...
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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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