Tag

80002-1
Partner and General Manager Brian Pate will be one of the faculty for the AAMI Application of Agile Practices course in Arlington, VA USA.  John Murray of FDA is tentatively scheduled to join Brian as faculty.  For more information, send a message below:
Read More
Regulatory Requirements for Software Validation in the Medical Industry
Read More
IEC 80002-1 Software Risk Management for Medical Device and HealthIT
Read More
Effective Application of Agile Practices in the Development of Medical Device Software
Read More
Here are some thoughts from a recent conversation between Sherman Eagles, Brian Pate, and Alan Kusinitz of SoftwareCPR®: Cybersecurity vulnerabilities can have unpredictable effects on safety.  Unpredictable effects … to those who have worked to reduce risks of software failures in medical device software, that phrase may be familiar.  That concept is explained in relation to...
Read More
“IEC TR 80002-1 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software” has been released. This standard was based on AAMI TIR32 but focuses on the 14971 perspective. AAMI has adopted TR 80002-1 as well and may obsolete TIR32 although there are some areas where TIR32 is...
Read More
Expand your access! Subscribe today!

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.