Day

October 3, 2007
The EU parliament released a final revision of the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). It includes a number of additions related to software. These additions and clarifications stress that standalone software can be a medical device but not all software used in healthcare is a medical device. It also...
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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
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