Registration
Course - CE-marking of Medical Devices in the EU
Nov 17, 2011
Stockholm,Sweden
The objective of this course is to give manufacturers of medical devices the knowledge and tools to efficiently develop their products in accordance to the requirements of EU Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC.The course is also relevant for manufacturers of stand-alone medical device software. The course will give the participants tips of many best practices gained from our experiences. It is also possible to discuss your specific questions.
Preliminary program:
08.30-09.00 Registration and coffee
09.00-12.00 Introduction
-EU Regulatory framework and requirements
-EU Medical Device Directive 93/42/EEC
-Classification
-Essential requirements
-Technical file, STED
-Conformity assessment routes
*one coffee break will be at appropriate time around 10.30
12.00-13.00 Lunch
13.00-15.00 EU Medical Device Directive 93/42/EEC, cont.
-Use of harmonized standards
-Clinical evaluations
-Vigilance reporting
-Post-market surveillance
-Field safety actions
15.00-15.30 Coffee
15.30-16.30 Issues related to software medical devices
16.30-17.00 Questions and discussion
Topics covered:
• EU regulatory framework for medical devices
• EU Medical Device Directive 93/42/EEC
• Product classification
• Essential requirements
• Use of harmonized standards
• Issues related to medical device software
• Conformity assessment route
• Technical documentation and technical file, STED
• Clinical evaluation
• Route to CE-marking
Speakers: Lian Zhang, Sr. Consultant and Robert Ginsberg, VP QA&RA
Who should attend:
- Regulatory managers and specialists
- Product developers, engineers
- SW developers, engineers
- QA managers
- Marketing managers
- Project leaders
- Clinical study managers / associates
- CEOs
Date and time: Thursday, November 17, 2011, 8:30 – 17:00
Location: Synergus AB, Svärdvägen 19, 182 33 Danderyd/Stockholm
Registration: info@synergus.com
Last day of registration: November 10, 2011, limited number of participants.
Please indicate clearly the course name and date
Course fee: SEK 6 000 excl. VAT/MOMS (Morning coffee, lunch and afternoon coffee are included). Please indicate special considerations on meals. Invoice will be sent upon confirmation of registration.
Cancellation policy: Cancellation of registration prior to the commencement of the event:
- 21–7 days, 25 % of the fee
- 7 days, full fee
You may replace one participant with another person if you inform us no later than 3 days before the event. Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances full course fees will be refunded.