62304 and Medical Device Software Stds Training

How does one know what standards are helpful when creating or updating your software development process?

Can compliance with standards benefit a medical device or HealthIT company with regulatory approval and/or FDA inspections?

These questions and more will be answered at the upcoming 62304 training and emerging standards impacting Medical Device software and Health IT training course sponsored by SoftwareCPR.  Stay one step ahead by learning about the amendment 1 changes to 62304, the upcoming 2nd edition of 62304, and how to frame your software development process around 62304. The course will even address challenges and recommendations for making your agile process 62304 compliant!   But the course is not limited to 62304 training – learn about the Health software standard, 82304, integrating 62366-1 into your SDLC, and the most efficient and appropriate software risk management methodologies.  Learn more about our 62304 training course!

Don’t wait for compliance issues – act now and make sure your company is not caught off-guard and lacking appropriate training.  Send us your questions below:

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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