Feature |
Premium |
Standards Navigator |
Standards Navigator PLUS |
A periodic email newsletter listing new items on the site and occasional analysis of selected items. |
X |
X |
X |
Checklists, Templates, Articles, Presentations, etc. |
X |
X |
X |
Emailed bulletins providing updates related to FDA software regulation and standards. |
X |
X |
X |
Searchable access to recent software warning letter and recall excerpts. |
X |
X |
X |
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. |
X |
X |
X |
Announcements of new medical device and health information technology software standards and guidance when they are proposed – before they are started. |
X |
X |
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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. |
X |
X |
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Discussions on new draft standards. |
X |
X |
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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. |
X |
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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. |
X |
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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:
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.
Includes all Premium Individual annual subscription benefits as above plus:
Includes all Standards Navigator subscription benefits as above plus:
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.