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Your experienced training specialists

Mr Paul Shane Bennetts

M. Devices Group

Mr Bernard Tremaine

M. Devices Group

TRANSFER KNOWLEDGE TO FAST TRACK YOUR CE PROGRAMME & MOVE AHEAD OF YOUR COMPETITORS

The Course Benefits

This is a practical introductory 1/2 day training courses to help delegates understand the European Council Directive 93/42/EEC:

• The Elements & structure of the Medical Devices Directive

• The importance of “Intended Use”.

• Understanding Classification

• Routes of Conformity & Notified Bodies

• An appreciation of the Essential Requirements

• Declaration of Conformity & the CE Mark

Who Should Attend

• Regulatory Assurance

• Quality Assurance

• Internal Auditors

• Device Development Managers

• Managers subcontracting device manufacture

An Introduction to the

European Council Directive

93/42/EEC

The MEDICAL DEVICES DIRECTIVE

&

the CE Mark

Dates by arrangement & Location at your premises

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