CRITICAL Software

Software development for MOBILE APPS 

Achieving Best Practice Through IEC 62304

Current trends in healthcare, such as the transition towards home-based care and personalised medicine, are driving the adoption of new technologies developed in the consumer electronics and mobile communications sectors. With these new opportunities come challenges.

In some cases, healthcare apps are treated for regulatory purposes as medical devices.  Developing software for medical devices is highly regulated, requiring manufacturers to understand risk management, controlled lifecycle management, validation and verification, configuration management and change control.

CRITICAL Software’s training course focuses on the development of mobile medical devices and how to efficiently conform to the legal requirements needed to sell to the EU, the US and the rest of the world. Standards covered include IEC 62304 for software development, ISO 14971 for safety risk management and IEC 62366 for human factors and usability engineering. 

Key Features:

 

Attendees will learn:

  • Learn about the legal processes involved in the sale of medical devices and the importance of software approval
  • Understand the role of regulators, standards and other organisations involved in industry standards like IEC 62304, ISO 14971 and IEC 62366
  • Learn about management systems, risk management and safety classification in the context of IEC 62304
  • Learn how IEC 62304 impacts the software development process, requirements analysis, architectural design and testing
  • Understand more about software maintenance processes, problem and modification analysis and change management

 
  • About the objectives, scope and key  principles behind behind the relevant industry standards
  • How to get to grips with safety and product lifecycles in the context of these standards
  • How these standards impacts system design and development processes
  • About what is required to demonstrate compliance with these standards

If required, the training course can be provided at client premises and is able to be tailored to suit client needs. Register your interest and one of our friendly experts will get in touch with you to discuss your options and how we can help.

 

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