Subscribe

Feature

Mailing List Only

 Standards Navigator

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

X

 X

Checklists, Templates, Articles, Presentations, etc.

X

 X

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

X

 X

Searchable access to recent software warning letter and recall excerpts.

X

 X

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

X

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

Discussions on new draft standards.

X

Technical and Regulatory Q&A via website

Up to 10 per year

Mailing List Benefits

Through blog posts and downloadable content, our SoftwareCPR® partners and guest 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.
Standards Navigator Benefits
For a higher level of service, we encourage our Standards Navigator subscription.  In addition to the mailing list benefits above, our SN subscribers receive:
  • Monthly update, with analysis, on medical device software, risk management, and health information technology standards and guidance that are being developed or modified.
  • Discussions on new draft standards.
  • Web based Q&A with our standards experts each of whom has personally participated in standards development.
  • 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.
  • Announcements of new medical device and health information technology software standards and guidance when they are proposed – before they are started.

Cost:  Our Standards Navigator subscription is $3,995 per year, or $400 per month (limited time offer).  Contact our office to subscribe.  We can accept credit card, pay by check, or direct electronic payment.  We can also create an invoice for processing if needed.Email us at office@softwarecpr.com