UPCOMING COURSES
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MARCH
2
Good Clinical Practice (GCP)
Berghem, the Netherlands
3
Audits and Inspections
Berghem, the Netherlands
4
Medical Devices
Lund, Sweden
9
Effective Site Management - A two-day course
Espoo, Finland
16
Medical and Scientific Writing
Lund, Sweden
23
Audits and Inspections
Lund, Sweden
23
Medical Devices
Stockholm, Sweden
24
Medical Devices
Espoo, Finland
24
Pharmacovigilance
Stockholm, Sweden
25
Audits and Inspections
Stockholm, Sweden
30
Effective Site Management - A two-day course
Berghem, the Netherlands

Medical Devices

March, 04, 2010, Lund, Sweden
Description  
• General 
    - MDD - Medical Device Directive 
    - National requirements 
    - Notified Bodies 
    - Reporting - requirements
• Country specific experience of working in: 
    - Europe (different countries within EU) 
    - USA
• Registration of a product 
    - CE-labeling (Europe) 
    - 510k/PMA (USA) 
    - Classification of a product 
    - Risk analysis 
    - Instructions for use and labelling
• Clinical Investigations when, where and why 
    - When to do a Clinical Investigation 
    - Differences between Europe and US - Ethical Aspects 
    - ISO 14155 -1 and 2 
    - Clinical Evaluation
• Group work and presentations  

Target group  
Those who come in contact with Clinical Investigations with Medical Device both national and international. Research personnel (Clinical and Pre-Clinical), study personnel at hospitals or private clinics and Marketing (how to use Clinical results).

The course will be provided in English.
Download fact sheet for this course
Annelie Andersson
Project Manager, TFS-Gothenburg
Cost
The cost for the course is EURO 375 + VAT when applying one month prior to the date of the course. An application after that date costs EURO 400 + VAT. The price includes morning and afternoon coffee as well as lunch.