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Good Management of Medical Devices: Legal and practical aspects

Jun 23 2014 8:00AM - Jun 25 2014 4:30PM | NH Musica van Leijenberghlaan 221 1082 GG Amsterdam Netherlands

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This course will give clear and practical guidelines on how to develop a medical device and how to identify the correct development path.

Overview of the EU device legislative system and the principles and philosophy behind it will be discussed. Instructors will also explain the essential features of medical device regulation, such as essential requirements, risk classification, the relationship between risk classification and conformity assessment procedures and the role of notified bodies.

For medical devices that need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be described in detail.

Furthermore, the process of drafting a design dossier will be highlighted, both for medical devices and for combination products.


What the participants from the previous Medical Devices course say:

"Very good with overall objective: difference between Pharma and device world"

What You Will Learn 

  • Medical device regulation: philosophy, content and structure
  • 93/42/EC, as amended by 2007/47/EC
  • CE mark
  • ISO 14155, ISO 13485 and ISO 14791
  • Risk-classification of medical devices
  • Drug-device combination products
  • Clinical evaluation and clinical investigation
  • Medical devices vigilance system
  • Recent and upcoming legal changes

Who Should Attend 

This course is designed for professionals starting work in industry and regulatory bodies, who would like to get acquainted quickly with all aspects of medical device regulation.

This course is also aimed at professionals in pharmaceuticals (e.g. regulatory affairs, clinical development), who would like to obtain an overview of device regulation, or who are involved in either drug-device combinations or medical devices.

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Apply the principles of medical device regulation
  • Classify medical devices according to rules for risk classification
  • Identify the applicable conformity assessment procedure
  • Understand the issues surrounding combination products (including ATMPs)
  • Conduct a medical device trial according to ISO 14155
  • Understand ethical and regulatory considerations of medical device trials
  • Understand the practical differences between medical device and drug development
  • Identify responsibilities in post-marketing surveillance
  • Evaluate risks and handle incident reports

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Hotel & Travel 

This course will take place at:

Hotel NH Musica

van Leijenberghlaan 221

1082 GG Amsterdam

The Netherlands

Tel: +31 20 79 56 088

E-mail: nhmusica@nh-hotels.com


DIA room block expired on 20 May 2014. Please contact the hotel for the availability and the best price.


HOW TO GET THERE: From Schiphol Airport, take the Sprinter Lighttrain toward Amsterdam RAI, Almere Oostvaarders or Hilversum. You will arrive at the the RAI train station in 10-14 minutes. From the RAI train station, take bus 62 toward Station Lelylaan and get off at the Bouvigne stop. Continue on Van Nijenrodeweg on foot and then turn left onto Van Leijenberglaan. The hotel will be on your left.

Contact Information 

DIA Europe
Kuechengasse 16
4051 Basel

Tel: +41 61 225 51 51
Fax: +41 61 225 51 52
E-mail: diaeurope@diaeurope.org


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Registration Fees 


Charitable Nonprofit/Academia Member
Member Government
Member Standard


Charitable Nonprofit/Academia Nonmember
NonMember Government
NonMember Standard
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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