True or False:
With regard to corrective and preventive actions, adds the specific requirement to define requirements for “verifying that the action does not adversely affect the ability to meet applicable regulatory requirements
True
100
Audit focused in a product line and related systems
Unnannounced
100
True or False: 4.2.3 Medical Device File is a new sub-clause
True
100
A product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions
Medical Device
100
How many years are required to implement a new standard?
3 years
200
Published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices
ISO 13485
200
Types of audits performed once every three years
Unannounced and Recertification
200
Is it required a documented procedure for Management Review?
Yes
200
Natural or legal person with responsibility for design and / or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and / or manufactured by that person himself or on his behalf by another person(s)
Manufacturer
200
When was the ISO 13485:2016 published?
March 2016
300
Number of the Purchasing Sub - Clause
7.4
300
True or False: Management Review attendance is confidential
False
300
True or False: Clause 6.3 Infrastructure was added to the revised standard
False
300
Natural or legal person in the supply chain who, in his own behalf, furthers the availability of the medical device to the end user
Distributor
300
When is the due date for certification in the new version of ISO 13485?
March 2019
400
Application of risk management to medical devices
ISO 14971
400
Mention the three main ISO 13485 based audit types
Unannounced Surveillance Recertification
400
Acceptance criteria
Statistical techniques with rationale for sample sizes
Criteria for revalidation
Approval of changes to the processes
Are new requirements to be documented in which procedure?
Process validation
400
Result of a process
Product
400
Which country has a sooner due date for implementation of ISO 13485 and when is the due date?
Canada. Jan 1, 2019
500
Guidance on the application of ISO 13485:2003.
ISO 14969
500
Main system audited and clauses numbers
CAPA, 8.5.2 and 8.5.3
500
Name of 8.2.2 and 8.2.3 new sub-clauses
Complaint Handling and Reporting to Regulatory Authorities
500
Systematic process to collect and analyze experience gained from medical devices that have been place on the market
Post-Market Surveillance
500
List of the years that ISO 13485 has been revised including creation