CRITICAL Software

Software development for Medical Devices

Achieving Best Practice Through IEC 62304

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. The key, mandated software standard within the medical devices industry is IEC 62304.

CRITICAL Software’s two-day training course provides much needed clarification of IEC 62304’s requirements and scope, presenting a detailed examination of how they can be implemented by manufacturers looking to efficiently deliver safe, effective and secure medical devices that conform to industry best practice. A step-by-step breakdown of IEC 62304 will be accompanied by clear guidance on what its requirements mean in practice. 

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 IEC 62304
  • 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 IEC 62304
  • How to get to grips with safety and product lifecycles in the context of IEC 62304
  • How IEC 62304 impacts system design and development processes
  • About what is required to demonstrate compliance with IEC 62304

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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