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Online-Training / 4/22 - 4/24/2024

Certified Professional for Medical Software® - Foundation Level

Categories Software-Development for Medical Products

General Information
Code
CPM-24-002
Location
Online-Training
Date
4/22 - 4/24/2024
Duration
3 Days
Time
09:00 AM - 05:00 PM
Centr. European Time (Berlin)
Language
English
Examination Fee
€ 215.00 per participant
Online Price
€ 1,700.00 per participant, plus VAT

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.

Contents
  • 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.

Target audience

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).
Prerequisites
  • No pre-certifications are required. Basic knowledge of software development and medical device development is required to attend the training.
Examination
  • The price of the seminar does not include additional exam fees.

  • If the exam is passed, the certificate will be issued by the independent certifier International Software Quality Institute (iSQI).
More Dates & locations
Online-Training, Germany
Online-Training, Germany

Any Questions?

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Courses 2023/24
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General Terms & Conditions
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