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How to Create a Medical Software Development File according ISO 62304?

4727
Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more


The medical software is the driver of the digitalization of the healthcare systems and the medical products in diagnostic and therapy. This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation. In the technical documentation is required to approve the development process and the life cycle of medical software according ISO 62304.

Course Objectives:

You should attend to understand how the ISO 62304 is working, what are the requirements and how is the ISO 62304 related to your medical software products and connected to you quality management system. You understand in this course how to apply the ISO 62304 in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the safety and performance requirements of the medical device regulation. In the technical documentation is required to approve the development process, the support process and the life cycle of medical software according ISO 62304.

Course Outline:

• What is the scope of the ISO 62304?
• What are the requirements of ISO 62304 in medical software development processes and the medical software life cycle?
• Which companies must apply ISO 62304?
• How to implement ISO 62304 in a smart way into a medical software development project and in a quality management system according ISO 13485?
• How to use the ISO 62304 in the Post Market Process according ISO 13485 and the EU MDR?
• What are the expectations of European Notified Bodies?

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Vice Presidents – Regulatory Affairs/Quality Assurance/Compliance
• Regulatory Experts
• Compliance Experts
• Medical Device Software Engineers and Managers
• Software Compliance Engineers
• Quality Managers, Engineers and Assurance personnel
• Regulatory Affairs Managers

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : How to Create a Medical Software Development File according ISO 62304?


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