Donawa Lifescience Consulting: Training

Donawa Lifescience Consulting offers training on different aspects of the European requirements for medical devices. These sessions are designed to be interactive and can be conducted either at client facilities, or at the Donawa Lifescience Consulting office in Rome. The following topics are currently available, but please contact us if you have specific requirements:

CEO PRIMER

The Donawa Lifescience Consulting Clinical Study CEO Primer is designed as short briefing sessions for senior company executives who do not need to understand the full detail of the many regulatory requirements that could affect the company's bottom line and future viability. This 2 to 4 hour package will, however, provide sufficient information for CEOs to be able to understand the many requirements and likely costs and timescales associated with conducting medical device clinical studies.

Click here for further information on the Clinical Study CEO Primer.

MEDICAL DEVICE CLINICAL STUDIES

Managing Device Clinical Studies: Regulatory Framework and Best Practices

Proper planning, management, and reporting of medical device clinical research must be well understood before embarking on 'first in man' studies. This session will cover many topics, including the European and US regulatory frameworks for device studies, international and national standards and guidance, the key elements of a device study, adverse event reporting, the clinical evaluation process, and the clinical summary report.
European Clinical Data Requirements - Preparing for the Revised Medical Devices Directive

The revision of the EU Medical Devices Directive will include important new requirements for the preparation of the clinical data needed to support CE marking. If you are developing a technical dossier, planning a clinical study in Europe, or managing clinical surveillance activities, this session will allow you to tailor your strategy to the changing regulatory environment.

Regulatory References