15 Questions
What type of audits may occur at any time within the audit cycle in case of noncompliance?
Special audits and unannounced audits
What is the purpose of the audit sequence in medical device manufacturers' audits?
To allow for logical, focused, and efficient audit conduct
What process do MDSAP audits follow?
Process based audits following 7 specific processes
What do Auditing Organizations do with the audit outcomes?
Share the outcomes with participating Regulatory Authorities
When are special audits and unannounced audits typically conducted?
In case of noncompliance within the audit cycle
What is the purpose of the list of Registrars Recognized by Health Canada?
To identify the registrars recognized by Health Canada for medical device auditing
What is the IMDRF MDSAP WG N4 focused on?
Competency and Training Requirements for Auditing Organizations
In the Auditing Organization Assessment Cycle, what occurs during Year 0?
Initial Assessment
What is the outcome of a Grade 1 nonconformity in Auditing Organization Assessment?
Unlikely to have a direct impact on the organization's operations
What is the purpose of On-Site Assessment of Critical Locations for Auditing Organizations?
To ensure compliance with regulatory requirements at critical locations
What is the scale used to grade nonconformities identified during an audit?
1 to 5
What triggers the performance of an unannounced audit in some cases?
High grade nonconformities
Which organizations will be allowed to apply to the MDSAP program for recognition?
Accredited organizations/registrars utilized in the Health Canada CMDCAS Program
What documents do Auditing Organizations issue upon successful certification or recertification audits?
MDSAP specific certification documents
What must the manufacturer provide and the Auditing Organization review after high grade nonconformities are identified?
Remediation plans and evidence of implementation of these plans according to a specified timeline
Test your knowledge about Health Canada recognized registrars and MDSAP auditing organizations. Explore the requirements for medical device auditing organizations and regulatory authority recognition.
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