RAC Devices Exam [ACTUAL EXAM]
LATEST VERSION [QUESTIONS AND
ANSWERS] WITH PRACTICE EXAM
DETAILED AND VERIFIED FOR
GUARANTEED PASS- LATEST
UPDATE 2025 GRADED A
What are the 6 general safety and performance requirements applicable to all medical
devices according to GHTF Essential Principles of Safety and Performance of Medical
Devices? - CORRECT ANSWER 1. Should be designed and manufactured in a way
that is safe and effective
2. Design and manufacturing should conform to current safety principles and risks
should be minimized
3. Devices should achieve the manufacturer's intended performance
4. No serious impact to characteristics/performance during lifetime under normal
conditions
5. Characteristics unaffected during transport and storage
6. Benefits outweigh risks
What are the 5 general requirements for conformity assessment? - CORRECT
ANSWER 1. Quality Management System (QMS)
2. Postmarket surveillance system (PMS)
3. Technical Documentation Summary
4. Declaration of conformity
5. Manufacturer and medical device registration with regulatory authority
What is a design space? - CORRECT ANSWER The multidimensional combination
and interaction of input variables and process parameters that have been demonstrated
to provide assurance of quality
According to GHTF, how do you comply with QMS process validation? - CORRECT
ANSWER Process validation uses objective evidence to prove a process consistently
produces a result or product meeting its predetermine requirements
1. Create a validation master plan
2. Choose team members from QA, engineering, manufacturing, etc.
, 3. Develop a protocol to define which processes and devices need to be validated
4. Select statistical methods for data collection and analysis
5. Create a maintenance plan and repair criteria
6. Develop revalidation critera
What is GHTF's recommended classification structure for IVDs? - CORRECT
ANSWER IVD classification depends on:
1. Intended use and indications for use
2. Intended user's technical, scientific, and/or medical expertise
3. Information's importance to diagnosis
4. Results possible impact on the individual and/or public health
What is the NIST cybersecurity framework? - CORRECT ANSWER 1. Framework
core: Identify, Protect, Detect, Respond, Recover (IPDRR)
2. The framework implementation tiers: tiers reflect progression from informal, reactive
responses to approaches that are agile and risk-informed
3. The framework profile
What is a NCAR? - CORRECT ANSWER National Competent Authority Report
(NACR) provides guidance, forms, and procedures for exchanging medical device
safety reports among national CAs and other IMDRF exchange program participants
Where are adverse events reported to? When are they reported? - CORRECT
ANSWER AE must be reported to national CA in country incident occurs, unless
specified differently in the applicable regulation.
1. Serious public health threat - no later than 2 calendar days after awareness
2. Any adverse event that results in death or unanticipated serious deterioration in state
of health no later than 10 calendar days
3. all reportable events no later than 30 calendar days
What is an FSCA and FSN? - CORRECT ANSWER Field safety corrective action
(FSCA) action a manufacturer takes to reduce the risk of death or serious deterioration
in the state of health associated with a medical device
Field safety notice (FSN): FSCA are reported and notified via FSN regardless of
whether they are associated with direct or indirect harm; issues to affect customers,
patients, and users and copies must be sent to CA of all affected countries
Single entity - CORRECT ANSWER Two or more components combined as integral
parts in a single unit. Prefilled syringes, metered dose inhalers, transdermal patches
Co-packaged - CORRECT ANSWER Two or more components that are distinct
entities that are combined in the same package. Convenience kits, drug dispensing
devices, drug/vial syringe packs
LATEST VERSION [QUESTIONS AND
ANSWERS] WITH PRACTICE EXAM
DETAILED AND VERIFIED FOR
GUARANTEED PASS- LATEST
UPDATE 2025 GRADED A
What are the 6 general safety and performance requirements applicable to all medical
devices according to GHTF Essential Principles of Safety and Performance of Medical
Devices? - CORRECT ANSWER 1. Should be designed and manufactured in a way
that is safe and effective
2. Design and manufacturing should conform to current safety principles and risks
should be minimized
3. Devices should achieve the manufacturer's intended performance
4. No serious impact to characteristics/performance during lifetime under normal
conditions
5. Characteristics unaffected during transport and storage
6. Benefits outweigh risks
What are the 5 general requirements for conformity assessment? - CORRECT
ANSWER 1. Quality Management System (QMS)
2. Postmarket surveillance system (PMS)
3. Technical Documentation Summary
4. Declaration of conformity
5. Manufacturer and medical device registration with regulatory authority
What is a design space? - CORRECT ANSWER The multidimensional combination
and interaction of input variables and process parameters that have been demonstrated
to provide assurance of quality
According to GHTF, how do you comply with QMS process validation? - CORRECT
ANSWER Process validation uses objective evidence to prove a process consistently
produces a result or product meeting its predetermine requirements
1. Create a validation master plan
2. Choose team members from QA, engineering, manufacturing, etc.
, 3. Develop a protocol to define which processes and devices need to be validated
4. Select statistical methods for data collection and analysis
5. Create a maintenance plan and repair criteria
6. Develop revalidation critera
What is GHTF's recommended classification structure for IVDs? - CORRECT
ANSWER IVD classification depends on:
1. Intended use and indications for use
2. Intended user's technical, scientific, and/or medical expertise
3. Information's importance to diagnosis
4. Results possible impact on the individual and/or public health
What is the NIST cybersecurity framework? - CORRECT ANSWER 1. Framework
core: Identify, Protect, Detect, Respond, Recover (IPDRR)
2. The framework implementation tiers: tiers reflect progression from informal, reactive
responses to approaches that are agile and risk-informed
3. The framework profile
What is a NCAR? - CORRECT ANSWER National Competent Authority Report
(NACR) provides guidance, forms, and procedures for exchanging medical device
safety reports among national CAs and other IMDRF exchange program participants
Where are adverse events reported to? When are they reported? - CORRECT
ANSWER AE must be reported to national CA in country incident occurs, unless
specified differently in the applicable regulation.
1. Serious public health threat - no later than 2 calendar days after awareness
2. Any adverse event that results in death or unanticipated serious deterioration in state
of health no later than 10 calendar days
3. all reportable events no later than 30 calendar days
What is an FSCA and FSN? - CORRECT ANSWER Field safety corrective action
(FSCA) action a manufacturer takes to reduce the risk of death or serious deterioration
in the state of health associated with a medical device
Field safety notice (FSN): FSCA are reported and notified via FSN regardless of
whether they are associated with direct or indirect harm; issues to affect customers,
patients, and users and copies must be sent to CA of all affected countries
Single entity - CORRECT ANSWER Two or more components combined as integral
parts in a single unit. Prefilled syringes, metered dose inhalers, transdermal patches
Co-packaged - CORRECT ANSWER Two or more components that are distinct
entities that are combined in the same package. Convenience kits, drug dispensing
devices, drug/vial syringe packs
