RAC Devices Verified Multiple Choice and
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. What is HTA? - ANSWER multidisciplinary process that uses explicit
methods to determine the value of a health technology at different points in its
lifecycle. The purpose is to inform decision making in order to promote an
equitable, efficient, and high quality health system
2. What are the 3 phases of HTA evaluation? - ANSWER Marketing
authorization: Evaluating a given technology's safety and
efficacy profile to support authorization for its use
ii. Technology assessment (HTA): systematic and multidisciplinary
evaluation which uses available data to support adoption and utilization in
the country or region
iii. Utilization decision making
3. 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? - 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
4. What are the 5 general requirements for conformity assessment? - 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
5. What is a design space? - ANSWER The multidimensional combination and
interaction of input variables and process parameters that have been
demonstrated to provide assurance of quality
6. According to GHTF, how do you comply with QMS process validation? - 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
7. What is GHTF's recommended classification structure for IVDs? - 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
8. What is the NIST cybersecurity framework? - 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
9. What are the 6 modules of EUDAMED? - ANSWER 1. Actor registration
2. UDI and device registration
3. Notified bodies and certificates
4. Clinical investigations and performance studies
5. Vigilance and market surveillance
, 10. Under EU MDR what are considered for rules? - ANSWER 1. Intended
purpose
2. Invasiveness
3. Contact type
4. Anatomical location
5. Energy source
6. Length of contact
11. Technical documentation per EU must cover - ANSWER Annex II and III
1. Device description and specification including variants and accessories
2. Labeling (including information supplied with the device)
3. Design & manufacturing information
4. General safety + performance requirements
5. Benefit-risk analysis and risk management
6. Product verification + validation
12. What is a NCAR? - 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
13. Where are adverse events reported to? When are they reported? - 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
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. What is HTA? - ANSWER multidisciplinary process that uses explicit
methods to determine the value of a health technology at different points in its
lifecycle. The purpose is to inform decision making in order to promote an
equitable, efficient, and high quality health system
2. What are the 3 phases of HTA evaluation? - ANSWER Marketing
authorization: Evaluating a given technology's safety and
efficacy profile to support authorization for its use
ii. Technology assessment (HTA): systematic and multidisciplinary
evaluation which uses available data to support adoption and utilization in
the country or region
iii. Utilization decision making
3. 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? - 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
4. What are the 5 general requirements for conformity assessment? - 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
5. What is a design space? - ANSWER The multidimensional combination and
interaction of input variables and process parameters that have been
demonstrated to provide assurance of quality
6. According to GHTF, how do you comply with QMS process validation? - 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
7. What is GHTF's recommended classification structure for IVDs? - 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
8. What is the NIST cybersecurity framework? - 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
9. What are the 6 modules of EUDAMED? - ANSWER 1. Actor registration
2. UDI and device registration
3. Notified bodies and certificates
4. Clinical investigations and performance studies
5. Vigilance and market surveillance
, 10. Under EU MDR what are considered for rules? - ANSWER 1. Intended
purpose
2. Invasiveness
3. Contact type
4. Anatomical location
5. Energy source
6. Length of contact
11. Technical documentation per EU must cover - ANSWER Annex II and III
1. Device description and specification including variants and accessories
2. Labeling (including information supplied with the device)
3. Design & manufacturing information
4. General safety + performance requirements
5. Benefit-risk analysis and risk management
6. Product verification + validation
12. What is a NCAR? - 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
13. Where are adverse events reported to? When are they reported? - 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
