NMJ30703

Please state the action when non conforming products are detected after delivery?

• Rework on the nonconforming products

• Record of the nonconforming products

• Eliminate the detected nonconforming products

• Issuing advisory notice in accordance with applicable regulatory requirements

How long shall a manufacturer retain records for each processes?

• Every 5 years

• Life-cycle

• After release into market

• Every 10 years

What is the right process for changes implementation. 

• Validated - Verified - Reviewed - Approved 

• Reviewed - Verified - Validated - Approved

• Reviewed - Validated - Verified - Approved

• Verified - Validated - Reviewed - Approved 

MS ISO 23485:2019 is a standard quality management system referred to by manufacturers to ensure safe and reliable medical devices are manufactured. Choose one element that ensures the conformance of the medical device. 

• Measurement, analysis and improvement.

• Management Responsibility

• 
  Resource Management

• Product Realization

Identify the activity that is not part of post-market surveillance.

• Complaint Handling

• Product Recall

• Field Corrective Action

• Market survey

Choose the guidance/standard document that is used in Common Submission Dossier Template

• ISO 13485

• Essential Principles of Safety and Performance

• IEC 60601

• IEC 62353

Identify one task that is not part of the requirement to market medical device in Malaysia

• Conformity Assessment

• Registration of Company with Medical Device Authority (MDA)

• Registration of Medical Device with Medical Device Authority (MDA)

• Registration of Medical Device with Conformity Assessment Body (CAB)

What is the classification for this Medical Device: endotracheal tube

• Class A

• Class B

• Class C

• Class D

What is the classification for this Medical Device: ventilator

• Class A

• Class B

• Class C

• Class D

What is the classification for this Medical Device: implantable cardiac defibrillator (ICD)

• Class A

• Class B

• Class C

• Class D