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Standards Navigator

Standards Navigator PLUS

A periodic email newsletter listing new items on the site and occasional analysis of selected items.

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Checklists, Templates, Articles, Presentations, etc.

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Emailed bulletins providing updates related to FDA software regulation and standards.

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Searchable access to recent software warning letter and recall excerpts.

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Annual Standards Landscape
Report on the current status of all pertinent medical device software and health information technology standards and guidance, including any new software standard or guidance that has been approved to begin development.

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Announcements of new medical device and health information technology software standards and guidance when they are proposed – before they are started.

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Frequent (typically monthly) updates with analysis.  Reports on medical device software, risk management, and health information technology standards and guidance that are being developed or modified as well as web-based Q&A with our standards experts each of whom has personally participated in standards development.

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Draft standards for comment as they become available.

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Real time Alerts when changes to software standards and guidance are being discussed that you have identified as being of particular interest to you.

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Up to 16 hours per year of off-site software standards-related consulting or training by SoftwareCPR®. This will be tailored to your preferences and could include, for example, periodic telecons, document or procedure review and feedback, or online training.

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Technical and Regulatory Q&A via website

Up to 5 per year

Up to 10 per year

Unlimited1

1 Technical and regulatory questions would be part of the 16 hours of consulting.

PREMIUM SUBSCRIPTION BENEFITS

Through blog posts and downloadable content, Alan Kusinitz, Sherman Eagles, Brian Pate, and other SoftwareCPR® experts keep you informed of new developments in FDA Software Regulation, enforcement actions, ISO standards related to medical devices, and also gain access to a wide variety of training aides, document templates, and checklists!  Some examples include:

Highlights:

  • IEC 62304 Checklist & 62304 Amendment 1 Checklist
  • IEC 62304 Document Training Templates
  • IEC 82304 Checklist
  • IEC 62366 Checklist
  • FDA 820 Part 11 Checklist
  • FDA General Principles of SW Validation Checklist, and many others
  • Searchable access to recent software warning letter and recall excerpts.
  • Email bulletins providing updates related to FDA software regulation and standards.  A periodic email newsletter listing new items on the site and occasional analysis of selected items.  To view our last newsletter click SoftwareCPR Last Newsletter.
  • Priority response to technical and regulatory questions posted on the site (Note: beyond 5 per year as time permits).
  • Standards Landscape report

A premium level subscription on the website provides high value at low cost to those interested in software safety, validation and FDA and international software regulation. Information on the site is updated and enhanced on a regular basis, newsletters are issued periodically, and email bulletins are sent for significant new developments.

We offer an individual (single email address) annual subscription and a company (up to 15 email addresses from same domain) annual subscription.

STANDARDS NAVIGATOR BENEFITS

Includes all Premium Individual annual subscription benefits as above plus:

  • Frequent (typically monthly) updates with analysis on medical device software, risk management, and health information technology standards and guidance that are being developed or modified as well as web based Q&A with our standards experts each of whom has personally participated in standards development.
  • Draft standards for comment as they become available.
  • Special SoftwareCPR® Standards Navigator documents and information, which contain the current status of all pertinent medical device software and health information technology standards and guidance, including any new software standard or guidance that has been approved to begin development.
STANDARDS NAVIGATOR PLUS BENEFITS

Includes all Standards Navigator subscription benefits as above plus:

  • Up to 16 hours per year of off-site software standards-related consulting or training by SoftwareCPR®. This will be tailored to your preferences and could include, for example, periodic telecons, document or procedure review and feedback, or online training.
  • Real time Alerts when changes to software standards and guidance are being discussed that you have identified as being of particular interest to you.
  • Announcements of new medical device and health information technology software standards and guidance when they are proposed – before they are started.

NOTE:  If you prefer to pay by check or direct electronic payment and need an invoice, email us at office@softwarecpr.com and indicate the type of subscription desired.

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