RAC DEVICE FINAL PAPER 2026
QUESTIONS WITH SOLUTIONS GRADED A+
●● 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
●● 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
, ●● 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
●● 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
●● 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
QUESTIONS WITH SOLUTIONS GRADED A+
●● 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
●● 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
, ●● 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
●● 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
●● 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
