AAMI Agile Methods Compliance Course

Brian Pate, Partner with SoftwareCPR, will be teaching the “Effective Application of Agile Practices in the Development of Medical Device Software” in Arlington, VA, October 6 – 7, 2015. This course will help participants understand the challenges of using agile methods while conforming to IEC 62304 and 21 CFR 820.30 design controls. For more information, just email Brian at brian@softwareCPR.com or leave a message at the link provided.
SoftwareCPR can also provide more tailored training at your facility in these very important areas:

ISO 14971 Risk Management
IEC 62304 Software Development Processes including Agile Methods
IEC 62366 Usability and Human Factors Engineering with Risk Focus
ISO 13485 Quality Management Systems

Our onsite courses can be provided in a general approach to teach the standards or tailored to your products and risk levels. Each course can be offered in 1, 2, or 3 day formats depending on the number of exercises provided. All our courses can typically be used to satisfy your training requirements. For more information, just email Brian at brian@softwareCPR.com.

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!

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15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.