Page 16 Dubai

Medical Devices

ISO 13485:2016 & CE Marking

Our ISO 13485 quality management training will help you to demonstrate your ability to provide medical devices and related
services that consistently meet customer requirements and regulatory requirements

ISO 13485:2016 Requirements IRCA Certified ISO 13485:2016 Medical
Discover ISO 13485 and how it can improve your business Find Devices – Quality Management Systems
out how the standard impact the development and production of Auditor/Lead Auditor (A18190)
medical devices
Learn about the concepts of medical devices risk management
MONTH DAY LOCATION (ISO 14971) and its integration with the audit approach
March 12 Dubai, UAE MONTH DAY LOCATION
July 9 Dubai, UAE March 19-23 Dubai, UAE
November 12 Dubai, UAE July 16-20 Dubai, UAE
1 day USD 1,565 November 19-23 Dubai, UAE
5 days USD 7,145

ISO 13485:2016 Implementation Introduction to CE Marking
Discover step by step how to design, plan and put in place your own Gain an introduction to the Medical Device Directives (MDD, AIMDD,
ISO 13485 and make sure your devices meets quality expectations IVDD) and cover their background and key features
MONTH DAY LOCATION MONTH DAY LOCATION
March 13-14 Dubai, UAE March 27 Dubai, UAE
July 10-11 Dubai, UAE July 24 Dubai, UAE
November 13-14 Dubai, UAE November 26 Dubai, UAE
2 days USD 3,130 1 day USD 1,565

ISO 13485:2016 Internal Auditor Medical Devices CE Marking
The course covers the planning, preparation, conducting, reporting Examine European medical devices regulatory and standards
and closure of internal audits principles, focusing on sound implementation of the regulatory
requirements
MONTH DAY LOCATION
MONTH DAY LOCATION
March 15-16 Dubai, UAE
July 12-13 Dubai, UAE March 28-30 Dubai, UAE
November 15-16 Dubai, UAE July 25-27 Dubai, UAE
November 27-29 Dubai, UAE
2 days USD 3,130
3 days USD 4,225

16 bsigroup.ae/training I +971 4 336 4917 I bsi.me@bsigroup.com
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