Let Alan Kusinitz and other SoftwareCPR® experts keep you informed of new developments in FDA Software Regulation, enforcement actions, and related standards activities and gain access to a variety of training aides, document templates, and checklists for as little as $250/year.

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Annual Basic Subscription Benefits

  1. Access to selected training material including Some examples are:
  2. IEC 62304 Checklist
  3. IEC 62304 Document Training Templates
  4. IEC 82304 Checklist
  5. IEC 62366 Checklist
  6. FDA Part 11 Checklist
  7. FDA General Principles of SW Validation Checklist, and many others
  8. Searchable access to recent software warning letter and recall excerpts as well as all software excerpts in a convenient single pdf file format, a Part 11 only warning letter pdf, and a recalls pdf. Email bulletins providing updates related to FDA software regulation.
  9. A periodic email newsletter listing new items on the site and occasional analysis of selected items.
  10. Priority response to technical and regulatory questions posted on the site (beyond 5/year as time permits).

A subscription to premium content and services 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.

Standard Annual subscription options include single user ($250), site ($500), and company (or large division of a multinational corporation)($1000). Regardless of the option, training documents can be shared with others in your company.

Standards Landscape and Quarterly Newsletter Subscription Add-on

Let Sherman Eagles provide in depth information regarding medical device standards, and general software and systems engineering standaards, via our Standards Landscape Document and Quarterly Newsletter as an add-on to our standard subscription for as little as $200/year single user, $400 site license, or company license (or large division of a multinational corporation)($750) .

Premium Standards Navigator Subscriptions

For those needing extensive information and analysis of Standards including standards under development consider our premium Standards Navigator and Standards Navigator Plus Annual subscriptions ($5000 or $9800/year respectively). This includes monthly newsletters and access to publicly available draft standards. Click Standards Navigator Monthly Report Example to see an example of it's monthly update. The Standards Navigator Plus subscription includes 16 hours of consulting from Sherman.Click Standards Navigator for more information on these premium subscriptions.

SoftwareCPR®, has expanded this subscription service beyond software, to cover news about proposed regulatory changes and standards activities relating to general aspects of medical devices. These include quality systems, risk management, human factors and product safety standards applying broadly to medical devices. Included in the standards we will report on are changes to the IEC 60601-1 series, ISO 13485, ISO 14971 and IEC 62366. In addition, Standards Navigator will report on trends on regulation in areas of rapid change such as Health-IT, medical device security and mobile medical device apps.

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To see a list of some of the educational aides, validation and procedural examples on this site click Topics or to browse all items click Library .