Labelling and Instructions for use (IFU) for Medical Devices and IVDS

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Management Forum have been running a fast developing and hugely successful MEDICAL DEVICE conference schedule for many years. During this time, major changes in device technology, delivery systems and regulatory requirements have occurred. These changes have all been reflected through 100’s of quality conferences and seminars as we continue to deliver up-to-date and topical information to the medical device industry.

Understand the requirements, regulations and developments in this important area

Key topics to be covered at this seminar:

• Requirements for Labelling Medical Devices
• GMDN: Generic Medical Device Nomenclature
• What are the Requirements for Labelling IVDs?
• Translation of Labelling – Process and the National Transpositions
• Alternative Labelling Proposals for Medical Devices
• Instructions for Use (IFU) for IVD medical devices – How to Provide Them to the Users
• Unique Identifiers and Bar Codes
• Global Harmonization Task Force Labelling Document
• The Importance of How to Identify the Manufacturer on Your Labelling

Chairman:

John Webster Managing Director, Medical Devices Consultants International, UK