Day

September 20, 2013
The Therapeutic Goods Administration of the Australian Department of Health released a document on 13-Sep-2013 entitled “Regulation of medical software and mobile medical ‘apps’.”  This explains at a high level Australia’s approach to regulation of medical software.  It indicates a risk based approach is taken and that all medical devices are expected to meet the...
Read More

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

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