FDA Presentation: ISO 13485 and Risk Management

FDA’s Quality System Expert Kim Trautman gave a presentation entitled ” ISO 13485, GHTF, MRA and Quality System Regulation Update”. The slides are at the link provided. They describe the status and direction and international standards related to global harmonization and the changes in ISO 9000. They also stress the importance of integrating risk management into the quality system.

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

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