RAC Devices Exam Questions with 100% Correct Answers
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RAC Devices
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RAC Devices
RAC Devices Exam Questions with 100% Correct Answers
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 medica...
RAC Devices Exam Questions with
100% Correct Answers
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
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
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
, 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
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
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? - 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 - Answer- Two or more components combined as integral parts in a single
unit. Prefilled syringes, metered dose inhalers, transdermal patches
Co-packaged - 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
Co-labeled or cross-labeled - Answer- Two or more components that are distinct in form
and packaging but are able to be used together according to the label. Photodynamic
therapies, surgical sealants and applicators
What is the difference between a companion diagnostic and a combination product? Is
a companion diagnostic considered a combination product? Why or why not? - Answer-
1. Co-labeled or cross-labeled combination products should not be confused with
companion diagnostics
2. Companion diagnostic: IVD that provides information essential for safe & effective
use of a corresponding therapeutic (drug or biologic)
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
Under EU MDR what are considered for rules? - Answer- 1. Intended purpose
2. Invasiveness
3. Contact type
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