Services, Training & Education

Training & Education

Clinical Investigations with Medical Devices (EU & USA) (3-day course)

This course is designed for anyone involved in pre- and post-market studies within the medical device industry. Developing medical devices and therapies is a complex and costly matter and can take many years to complete. This course covers all aspects of clinical research activities that are performed during pre- and post-market studies.

Details

Reservations:

23 - 25 June 2009

20 - 22 October 2009

CE-Marking (MDD)

The MDD’s main purpose is to harmonize national controls to allow free movement of medical devices throughout the European Union and the European Free Trade Associations while ensuring that all devices within the European Union are reasonably safe to use. genae’s medical device experts assist you in complying with the Medical Device Directive. On request, we will send you our report on obtaining the CE mark and on how we determine your device classification, check all relevant essential requirements, prepare the relevant technical documentation and on how we communicate with the Competent Authorities and Notified Bodies on your behalf.

Reimbursement

Services include:

• Verification and assessment of the existing clinical data.
• Collection of technical and clinical data from the original Technical File.
• Formulating rationale.
• Preparation, production and submission of the reimbursement dossier.
• Follow-up and tracing.

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