Regulatory Requirements on Medical Devices

This is how your training course could look like:

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Please note that we need about 3 months preparation for the organisation of your in-house training course.

08:00 – 08:30	Welcome, Introduction, Presentation of the Speaker
08:30 – 10:30	Regulatory Requirements in Europe and Harmonisation Regulation ISO Norms IMDRF/GHTF Guidelines MedDev Guidelines Notified Body Recommendations
10.30 - 10.45	Break
10.45 - 12.00	Regulatory Requirements at the FDA CFR 820 ff Guidelines
12.00 - 12.45	Differences between EC and FDA Requirements Differences and common interests

12.45 - 13.45	Lunch
13.45 - 15.15	CE-Certification Requirements of the EC Regulation Use of harmonised norms Certification Process
15.15 - 15.30	Break
15.30 - 17.00	Technical Documentation Content of the TD TD as a linking document between production and quality control Change Management
17.00 - 18.15	Final Discussion Forum