Agile Methods Planning Recommendations

It is well established that design and development planning is a critical component of developing safe and effective medical device software. Planning ensures that the design process is appropriately controlled and that the quality objectives are met.
However, when medical device companies adopt agile methods for software development, the planning process can be confusing and challenging. Many aspects differ with traditional waterfall approaches and the development and QA managers struggle with knowing how much planning is required.

The document at the link provided is a brief overview on this subject along with several recommendation by Brian Pate of SoftwareCPR.

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

for more info!

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