Certified Professional for Medical Software^® - Foundation Level

The internationally valid certification for Certified Professional for Medical Software - Foundation Level (CPMS) pursues the goal of creating a uniform, recognized level of training for professional developers of medical software. With the knowledge imparted in this context, costs can be saved in software development and superfluous work steps can be avoided.

内容

• Regulatory landscape
  • Legal foundations
  • The European regulations
  • The harmonized standards
  • Controls
  • Regulations outside the EU
• Medical informatics
  • Informatics in health care
  • Interoperability
• Risk Management
  • Introduction to Risk Management
  • The risk management process according to ISO 14971
  • Risk Analysis Process
• IT Security
  • General requirements
  • Process requirements
  • Requirements for the product
• Software engineering and IEC 62304
  • Software development process
  • Development planning
  • Software requirements analysis
  • Software architecture
  • Software Design
  • Software Implementation
  • Software Integration
  • Software Testing
  • Software Release
  • Software Configuration Management
  • Software Maintenance
  • Software Problem Solving
  • Software of Unknown Provenance (SOUP)*Usability
  • Basics Usability
  • Regulatory requirements
  • Requirements of IEC 62366-1
  • From context of use to requirements of use
  • User interface
  • Methods of evaluation
  • Documentation
• Quality and document management
  • Quality Management
  • General requirements for documentation
  • Required documentation

With the Certified Professional for Medical Software - Foundation Level certification, you possess an internationally recognized certification. Gain an overview of quality management in medical software development and the associated document and risk management. Learn the regulatory requirements of medical software. Gain an overview of the special requirements of medical software.

目标人群

The training is aimed at all those interested in the topic of development and quality assurance of software in medicine. It is particularly interesting for people working in the following areas:

• Software design, development, architecture for medical software,

• system analysis,

• Project management, quality management, project management, product management, regulatory affairs management,

• Authorities with a supervisory function (regional councils, trade supervisory offices).