GDPMD ASSESSMENT AUGUST 2020

GDPMD ASSESSMENT AUGUST 2020

Assessment

Assessment

Created by

Purani S

Professional Development

Professional Development

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10 questions

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1.

Multiple Choice

30 sec

1 pt

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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

30 sec

1 pt

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The GDPMD certification is to be conducted by the non- registered conformity assessment body (CAB).

True

False

3.

Multiple Choice

30 sec

1 pt

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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

30 sec

1 pt

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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

30 sec

1 pt

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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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