Content of the E-Learning Programm

Learn how to market your medical device

The training videos open the door to a quality approved auditor knowledge. These materials are not only used by hundreds employees of medical device manufacturers, but also by notified bodies. It includes

  1. 60+ instructional training videos
  2. Ready to use templates and example documents (premium version only)
  3. Self-assessment 
  4. Personal support

1. More than 60+ training videos

The comprehensive series of instructional training videos teach everything companies need to compile submission documents and to pass quality management inspections respectively audits. 

Subject Total of Videos Target Audience
Developer Product Manager Risk Manager Quality Manager Regulatory Affairs Manager
Classification of Medical Product 2
Regulatory Basics 10
General Requirement of Technical Documentation 1 (√)
Formulating law-compliant Product Purpose 2 (√)
Creating Risk Management Document according to ISO 14971 16
Documenting IEC 62304-compliant Software-Lifecycle including Software Requirements, Software Architecture, Software Testing und Software Release 15 (√) (√)
Creating IEC 62366-compliant Usability Documents 6 (√) (√)

2. Templates, Sample Documents & Checklists

With the templates and sample documents in the premium version, part of your work is already done: Just fill out these documents and evaluate them afterwards using the checklists. This way you will succeed in doing document reviews quickly and effectively.

Read more about the templates

3. Self-Assessment

With the Mindmailer, an email-based self-assessment which is adjusted exactly towards the video sessions, you can check whether you have understood everything correctly at anytime and everywhere. Companies also use Mindmailer to achieve success in their trainings. Just like it should be according to FDA QSR and ISO 13485.

4. Personal support

If you as require additional, personal support to discuss all individual questions and to find specific solutions for your specific case, we include two hours of online consulting (premium version only). You can purchase additional time of our consulting services (billed by hour).


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