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Wednesday
02
MAY

Medical Devices Awareness Training - Certification

09:00
17:00
Steinbeis Malaysia Foundation
Event organized by Steinbeis Malaysia Foundation

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AWARENESS TRAINING OF GDPMD, ISO 13485:2016, PRODUCT VERIFICATION, PRODUCT CONFORMITY
(HRDF CLAIMABLE)
Date : May 2, 2018
Venue : A-13A-02, The Vertical Business Suites, Bangsar South, Kuala Lumpur
Time : 9.00am to 5.00pm
Course fees : RM600.00 (early bird – before April 25th, 2018)
: RM650.00 (normal fee – April 25th, 2018 onwards)
* Limited to 30 participants only
*Payment may be made into the following account: Steinbeis Malaysia Foundation A/C: 5124 4660 4652 Malayan Banking Berhad
Please register your participation and upload proof of payment at http://bit.ly/STMYregistration
Course Objectives
The training provides:
• Understand the definition of a Medical device and what ‘intended use’ actually means for 13485 and
GDPMD compliance
• Understand the intent and scope of the 13485 and GDPMD standard
• Have a practical, working knowledge of the QMS and people’s responsibilities in maintaining
compliance with this Standard
• To understand the requirement to register the medical device before place into the market
Key Offerings
• QMS Review the changes of ISO13485
• Give participants an awareness of ISO13485 and its alignment to respective Quality System Regulation
• Assist participants in the relationship between QMS and product registration
• Identify what ISO13485 and GDPMD requires and also what is MDA expectation
Schedule and Hours
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an
opportunity for further questioning and discussion with the instructors.
Certificates
Certificates will be provided to all attendees for attended at least 80% of the programme