SoftwareCPR.com Subscriptions

Let Alan Kusinitz and other SoftwareCPR experts keep you informed of new developments in FDA Software Regulation, enforcement actions, and related standards activities.

Let Sherman Eagles and other SoftwareCPR experts provide in depth information regarding medical device software standards with our premium Standards Navigator and Standards Navigator Plus monthly subscriptions.  Click Standards Navigator for more information on these premium subscriptions.

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 .
To get additional information or to order send email to office@softwarecpr.com or click Catalog  then select annual subscriptions - view products. 

Annual Subscription Benefits

  1. Access to selected training material including visual aides, annotatd FDA documents, software document and SOP examples,  templates, and checklists for IEC 62304, Part 11, FDA GPSV, premarket submissions, and many other topics.

  2. 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.
  3. A periodic email newsletter listing new items on the site and occassional analysis of selected items.

  4. 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 EU 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. 

Click Newsletter to see a recent example.

Annual subscription options include single user ($250), 5 user ($350), site ($500), and company (or large division of a multinational corporation)  users ($1000). Regardless of the option, training documents can be shared with others in your company.

Alan Kusinitz
Managing Partner

Click here to leave a message
781-721-2921

20 Berkshire Drive  Winchester, MA 01890 USA

  1. Access to selected training material including visual aides, annotatd FDA documents, software document and SOP examples,  templates, and checklists for IEC 62304, Part 11, FDA GPSV, premarket submissions, and many other topics.

  2. 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.
  3. A periodic email newsletter listing new items on the site and occassional analysis of selected items.

  4. 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 EU 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. 

Click Newsletter to see a recent example.

Annual subscription options include single user ($250), 5 user ($350), 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.

Alan Kusinitz
Managing Partner

Click here to leave a message
781-721-2921

20 Berkshire Drive  Winchester, MA 01890 USA