In Vitro Diagnostic Medical Devices

Building the Technical File and Demonstrating Compliance

Course Objectives:

This program is designed to provide participants with a variety of knowledge and skills:

• Know the requirements for CE marking of in vitro diagnostic medical devices according to Directive 98/79/CE
• Acquire a practical methodology for preparing the technical documentation according to Annex III.3, III.6, IV.4 and V.3
• Identify data to include information on system quality, design manufacture, risk analysis, performance evaluation and stability studies

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To get a detailed curriculum, find out scheduled locations or request this program in your area, contact LNE/G-MED America.

For an economical way to train multiple staff, ask us about an on-site program at your company.