E-Learning Program: The Premium Version

The premium version additionally contains 

  1. Templates and example documents
  2. Extended support
ElementProfessional VersionPremium Version
Video trainings
Self-Assessment (Mindmailer)
Support√ (basic)√ (extended)

1. Templates

a) List of templates

Here are the lists of current templates, which we continuously expand:


  • Intended Use
  • Clinical Evaluation
  • Classification according to MDD
  • MDD chcklist
  • Declaration of Conformity
  • Glossary


  • Software Requirements Specification
  • Checklist: Review of Software-requirements in Word and PDF Format
  • Software Architecture
  • Checklist: Review Software Architecture
  • Checklist: Software Release
  • Protocol: Software Test System

Risk Management File

  • Risk Management File
  • Risk Management: Risk Acceptance Matrix, Risk Tables, Risk Assessment

Usability File

  • Usage Scenarios
  • Main Operating Functions
  • Usability Specification 
  • Validation Plan
  • Validation Results Documentation

Are there any documents missing? Let us know, we would like to help you!

b) Structure and content of templates

The templates are as comprehensive as possible. They contain

  • Cover sheet
  • Chapter structure
  • Example content
  • Instructions how to fill the blanks
  • Translation into English and German

Would you like to take a better look on the templates?  We can arrange a web conference to go through each document with you, contact us now!

2. Extended Support

Our premium members have our highest priority. We not only provide support on how to use the e-learning program but additionally include an complimentary two hour consulting via web (conference) or email to answer project or product specific questions.

Our support is staffed with top level experts for regulatory affairs, quality management and medical systems / software engineering.


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