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TMCNet:  Research and Markets: Medical Device Clinical Studies - Understand How to Conduct Pre and Post Market Medical Device Clinical Studies (Course, London)

[January 27, 2014]

Research and Markets: Medical Device Clinical Studies - Understand How to Conduct Pre and Post Market Medical Device Clinical Studies (Course, London)

DUBLIN --(Business Wire)--

Research and Markets ( has announced the addition of the "Medical Device Clinical Studies - Understand How to Conduct Pre and Post Market Medical Device Clinical Studies (Course, London)" conference to their offering.

The Medical Device Clinical Studies Course will take place on the 1st & 2nd April 2014 at the Rembrandt Hotel, London


- Understand the effect of regulatory requirements on medical device clinical studies

- Clarify what is involved in a Clinical Evaluation (Literature Review)

- Discover how to design pre market and postmarket clinical follow up studies

- Know what documentation is needed and what should go in a study master file

- Discover how to obtain Research Ethics approval in the countries of Europe

- Plan how to prepare regulatory notifications to the Competent Authorities

- Understand the key aspects of pre and post market study set up, management, monitoring and close down and the differences between medical device and medicinal product studies

- Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study

- Discuss how to prepare a paper or presentation for publication and marketing

This course has been designed specifically for those involved in conducting medical device clinical investigations and post market clinical follow-up studies. The colection of clinical data to demonstrate safety and performance of a device is pivotal to CE marking a medical device. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market.

This course will cover the full range of clinical research activities that should be applied during the collection of data for both pre and post market studies. It will provide delegates with information on the European regulations for conducting medical device studies and help them to run studies in Europe and other countries. Delegates should benefit from the advice and tips on the practicalities of conducting studies within Europe.


Participants should expect two extremely informative days with ample time for discussion, questions and case studies. Delegates will:

- Understand the role of clinical research in device development within the medical device industry

- Discover clinical trials methodology in the preparation and conduct of clinical trials of medical devices

- Take away practical knowledge on how to plan, organise and conduct clinical trials of medical devices successfully


This course will be of value to those who are involved in conducting medical device studies (clinical evaluations, clinical investigations and post market clinical follow up studies) and particularly where data may be used to support the CE marking process. Personnel involved in setting up, managing and monitoring studies will benefit from this seminar.

Those involved in research and development, marketing and regulatory would enhance their understanding of device studies by attending this course. It will be of interest to professionals at all levels either new to device studies or those wishing to update and enhance their current knowledge and skills. It will be particularly useful to those moving from pharma studies to device studies.

A Certificate of Attendance for Professional Development will be given to each participant who completes the course


1 & 2 April 2014


1 April 2014 Start: 09.30 - Finish: 17.00

2 April 2014 Start: 09.00 - Finish: 16.30


1 April 2014 09.00


The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS


Opposite V&A Museum. Nearest underground station: South Kensington.

NOTE: Events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged

For more information visit

About Research and Markets

Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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