CPMS CPMS Risk Management & Quality Assurance 2

Question 1

What does a Quality Management System (QMS) in the context of medical software development primarily ensure?

Accepted Answer

Consistent processes and controls to meet regulatory and customer requirements for quality

Answer

A QMS provides a structured framework of processes and controls to ensure medical software consistently meets regulatory requirements and customer quality expectations.

Question 2

Which standard defines quality management system requirements specifically for medical device organizations?

Accepted Answer

ISO 13485:2016

Answer

ISO 13485:2016 specifies QMS requirements specifically for organizations involved in the design, production, and servicing of medical devices.

Question 3

In medical software quality assurance, what is the purpose of a Corrective and Preventive Action (CAPA) system?

Accepted Answer

To investigate nonconformities, determine root causes, and implement actions to prevent recurrence

Answer

CAPA systems investigate nonconformities and defects, identify root causes, and implement both corrective actions to fix current issues and preventive actions to stop recurrence.

Question 4

What is 'nonconformance' in medical software quality management?

Accepted Answer

A failure to meet a specified requirement, standard, or regulatory obligation

Answer

Nonconformance is any failure to meet a specified requirement, standard, or regulatory obligation that must be documented and addressed through the QMS.

Question 5

Which process ensures that a medical software supplier meets quality and regulatory requirements before their product is used?

Accepted Answer

Supplier qualification and audit process

Answer

Supplier qualification involves evaluating and auditing vendors to confirm they meet required quality and regulatory standards before their software or components are incorporated.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS CPMS Risk Management & Quality Assurance 2