Training #01

Know the constituent elements of the technical documentation of medical devices to meet the requirements of Regulation (EU) 2017/745.

• Post-training evaluation questionnaire
• Training satisfaction evaluation questionnaire

Each participant will be able to :

• Understanding the technical documentation requirements according to Regulation (EU) 2017/745
• Define the classification of its medical devices
• Define the certification path adapted to its medical devices
• Build your technical documentation and update it if necessary

• Detailed training schedule
• Digital training materials
• Training evaluation questionnaires
• Results of trainee learning assessment
• Training certificate

• Regulatory and normative context
• Structure and content of technical documentation
• Difference in content between different certification routes and classes of medical devices
• Updating technical documentation: under what circumstances?

From €980
Price adapted to your needs, number of participants and type of training (inter / intra-company).
Contact us for a personalized quote

• Teaching aids (course support presentation, extracts from standards documents, document templates, etc.)
• Practical exercises, feedback, case studies based on your system