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.
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
Tel: +31 20 79 56 088
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.
Tel: +41 61 225 51 51
Fax: +41 61 225 51 52