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[Udemy] IEC 62304 – Medical Devices Software Development & Processes

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What you’ll learn

  • Comprehend the IEC 62304 commonplace and what components are there in software program lifecycle processes
  • Illustrate the FDA steering together with IEC 62304 and examine the sorts of softwares and dangers concerned
  • Evaluate the extent of dangers iterated in FDA steering on medical system software program and IEC 62304 and the way do they coorelate
  • Exhibit your understanding about several types of medical system softwares


  • A primary understanding of medical system and softwares working inside that business


This course on IEC 62304 is the primary interactive course on medical units software program growth. It’ll empower you to know how you can create and preserve secure software program for medical units all through their life cycles. You’ll achieve a sturdy understanding of essential terminologies to let you comprehensively take part in discussions about software program security classifications and software program danger administration. Together with this, you also needs to assimilate how IEC 62304 interacts with different requirements comparable to ISO 14971, ISO 13485, IEC 60601 sequence.

You should have limitless entry to the course and its academic supplies. The good worth inside our on-line programs is which you could pause, re-watch and begin once more watching on-line lectures the place you truly stopped. You are able to do this as many instances as you want with none limitation in anyway! This provides you with the consolation to be taught what, how, the place and if you need.

No must pay thousand {dollars} for sooner or later consciousness course on the design and growth of medical units software program. This course will suffice your requirement.

You’ll be taught the about this new commonplace IEC 62304 necessities on software program lifecycle growth.

You’ll be taught following if you take this course (Course Goals):

  • Fundamental details about the IEC 62304
  • Course of for Software Development
  • Security Classification
  • Documentation
  • Threat Administration Course of
  • Configuration Administration
  • Downside Decision
  • FDA, IMDRF Classification for SAMDs

Who this course is for:

  • The course is related for any skilled working with software program growth, comparable to R&D engineers, high quality assurance division and auditors of software program growth.
  • All these working in compliances for medical units business and wish to lengthen their data on software program medical units
  • Consultants working to assist their purchasers on medical units’ software program compliances

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