GDPMD ASSESSMENT AUGUST 2020

Assessment
•
Purani S
•
Professional Development
•
Professional Development
•
59 plays
•
Easy
Student preview

10 questions
Show answers
1.
Multiple Choice
GDPMD is aimed to demonstrate organization's ability to maintain quality and innovation of medical devices in compliance with the Malaysian medical device regulatory requirement.
True
False
2.
Multiple Choice
The GDPMD certification is to be conducted by the non- registered conformity assessment body (CAB).
True
False
3.
Multiple Choice
Quality is defined as meeting customer and regulatory requirement and the device is safe and performs as per its intended purpose.
True
False
4.
Multiple Choice
GDPMD guideline by Medical Device Authority (MDA MOH) is published to meet regulatory requirement as per Appendix 4 Schedule 3 of Medical Device Regulation 2012.
True
False
5.
Multiple Choice
Detailed description on how the relevant and applicable regulatory requirements are addressed for each medical device specified in the scope of the GDPMD regulatory compliance system must be documented in the Laboratory Compliance Manual.
True
False
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