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
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||√||√||—||—||√|
|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||(√)||√||—||(√)||√|
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.
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.
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).