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newsletter
SoftwareCPR September 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.
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SoftwareCPR August 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.
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SoftwareCPR July 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.
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Kicking off the new year with regulatory and standards updates.  New public courses in 2020!
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Registration for our 62304 and Emerging Standards software course February 4-6, 2020, in Sunnyvale, CA is in full swing!  Onward to higher software quality – keep pressing forward!
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August and September 2019 continued a busy trend of regulatory and compliance activity – there were 42 software related recalls!  We also announced our 2020 Public Training Course dates!  Onward to higher software quality – keep pressing forward!
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May and June 2019 was a busy period for software related recalls – there were 28 recalls as you will see later in the Newsletter. As you plan your software quality assurance activities, we encourage review of published recalls and consider what steps you have in your process to prevent similar problems. Onward toward higher...
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John F. Murray, Jr, will be teaching at our June 4-6, 2019, FDA and 62304 Software course in Boston. Our course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.
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Our March 2019 Newsletter has been published.  Learn of significant regulatory and standards related activity associated medical device software, medical mobile apps, and HealthIT software.  Also you can find dates for upcoming training opportunities.
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This SoftwareCPR.com newsletter in pdf form lists items added to the web site from early-June 2018 through mid-October 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated...
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Our newsletter in pdf form lists items added to the web site from mid-April 2017 through June 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated ones. SoftwareCPR-June2018Newsletter
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This newsletter in pdf form lists items added to the web site from mid-November 2017 through late-November 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated ones....
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This SoftwareCPR.com newsletter in .pdf form lists items added to the web site from mid-August 2017 through mid-November 2017. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated...
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This SoftwareCPR.com newsletter in .pdf form lists items added to the website from late-April of 2017 through mid-August of 2017. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or...
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This SoftwareCPR.com newsletter in pdf form lists items added to the web site from mid Late December 2016 through late April. 2017. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists...
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/docs/scpred/SoftwareCPR-Newsletter052016.pdf
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/docs/scpred/SoftwareCPR-NewsletterJune15.pdf
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This SoftwareCPR.com newsletter lists items added to the website from 7/22/2013 to 10/24/2013. It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and the related web page should...
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This SoftwareCPR.com newsletter lists items added to the website from Nov 9, 2009 to May 19, 2010 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and...
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This SoftwareCPR.com newsletter lists items added to the website from March 26, 2009 to November 9, 2009 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and...
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This SoftwareCPR.com newsletter lists items added to the website from Jan 1, 2009 to March 26, 2009 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and...
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This SoftwareCPR.com newsletter lists items added to the web site since March 21,2008 and as of August 6, 2008 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the...
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This SoftwareCPR.com newsletter lists items added to the website from October 16, 2007 to March 21,2008. It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and the related...
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SoftwareCPR Training Courses:

Risk Management (Public or Private)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective training course is now open for scheduling!

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

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

Instructors: Dr. Peter Rech, Brian Pate

Next public offering:  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 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

 

IEC 62304 and other emerging standards for Medical Device and HealthIT Software (Public or Private)

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, 2nd instructor (optional)

Next public offering:  TBD

 

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