Click here to close now.


News Feed Item

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

DUBLIN, Mar. 21, 2014 /PRNewswire/ --

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 collection 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

Key Topics Covered:

DAY ONE - 1 April 2014

Welcome, Introductions and Course Objectives

The Regulatory Framework Applicable to Medical Device Studies

- An overview of the regulations for placing medical devices on the market

- How the regulations effect device studies

- Standards and guidelines applicable to medical device studies, ISO, GHTF, MEDDEV and NBMED

Conducting a Pre Market Clinical Evaluation/Literature Review

- The Clinical Evaluation (Literature Review)

- What's involved and how it should be conducted

Example documents and templates will be provided to help delegates understand this process

Designing Pre Market and Post Market Studies

- What types of studies and study designs are applicable to pre and post market studies

- What to consider in designing and implementing appropriate pre and post market studies

Documentation for Medical Device Studies

- What documentation is needed

- How should this be produced, what should go in to a study master file

This presentation will include template documentation

DAY TWO - 2 April 2014

Ethical Considerations Throughout Europe for Pre and Post Market Studies

- How to obtain Research Ethics approval in each European Country

- What to provide, timescales and practicalities

Regulatory Clinical Investigation Notifications

- How to prepare regulatory notifications to the Competent Authorities

- What to provide, timescales and practicalities

Study Management and Monitoring

- Key aspects of pre and post market study setup

- Management, monitoring and close down

- Getting the best data

How to Write a Final Study Report for a Regulatory Clinical Investigation Pre Market Study

- Practical considerations for final study reports, publications and presentations of study results

Examples and templates will be provided to help delegates understand the processes

- How to prepare a paper or presentation for publication and marketing

Current Key Issues Affecting Medical Device Studies

- This presentation will provide an update on the current issues affecting medical device studies, it will include the effect of changes to the directives and current initiatives throughout Europe


Janette Benaddi is Director of Clinical & Consulting Europe for NAMSA-MEDVANCE. She has 20 years experience of managing clinical studies in both devices and pharmaceuticals throughout Europe. Prior to joining NAMSA-MEDVANCE, Janette worked in Paris for a medical device consultancy group as Project Director in Clinical Affairs. She has also worked with several multi-national organisations in clinical and regulatory roles. Her knowledge and experience in medical device clinical research is vast and covers all aspects of the process. Janette is a registered nurse, has a BSc and a Diploma in Management Studies, is a Chartered Scientist and also holds a teaching certificate. She is involved with several international committees governing medical device clinical studies. She has published a number of articles related to medical device clinical investigations.

Robin Stephens is Managing Director of Psephos Biomedica Limited. Robin specialises in clinical and regulatory services to the cardiovascular medical device industry. He has more than 20 years experience in clinical research and regulatory affairs for medical devices throughout the world, but principally in Europe. Prior to establishing Psephos Biomedica, Robin was the Director of International Clinical Research & Regulatory Affairs for Medtronic Vascular (previously AVE). Before joining AVE he was Managing Director of Global Regulatory Associates Limited and before that held several positions with CR Bard. Robin has been Scientific Adviser to a medical technology publishing house as well as being an author on regulatory matters and editor for a series of books on biomaterials. He has a BSc in Applied Chemistry/Biochemistry and is a member of the Royal Society of Chemistry.

For more information visit

Media Contact:

Laura Wood , +353-1-481-1716, [email protected]

SOURCE Research and Markets

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Cloud computing delivers on-demand resources that provide businesses with flexibility and cost-savings. The challenge in moving workloads to the cloud has been the cost and complexity of ensuring the initial and ongoing security and regulatory (PCI, HIPAA, FFIEC) compliance across private and public clouds. Manual security compliance is slow, prone to human error, and represents over 50% of the cost of managing cloud applications. Determining how to automate cloud security compliance is critical...
Internet of @ThingsExpo, taking place June 7-9, 2016 at Javits Center, New York City and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo New York Call for Papers is now open.
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
We are rapidly moving to a brave new world of interconnected smart homes, cars, offices and factories known as the Internet of Things (IoT). Sensors and monitoring devices will touch every part of our lives. Let's take a closer look at the Internet of Things. The Internet of Things is a worldwide network of objects and devices connected to the Internet. They are electronics, sensors, software and more. These objects connect to the Internet and can be controlled remotely via apps and programs. ...
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, explored the IoT cloud-based platform technologies driving t...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
As organizations shift towards IT-as-a-service models, the need for managing & protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection & E-Discovery of your data - whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise.
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).