Day

July 27, 2012
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Mary Decareau of SoftwareCPR prepared a tiered checklist for EN 62366 Medical devices – Application of usability engineering to medical devices for our internal use and we are making it available to paid subscribers at the link provided and...
Read More
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The SFDA prepared a draft document entitled "Explanations on the Basic Requirements of Application for Registration of Medical Device Software" on April 28, 2012, which is linked below. This was initially translated to English by JIRA (Japan Industries Association...
Read More

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.