RA Specialist Interview Prep Flashcards

Question

What is a gap analysis in regulatory compliance?

Answer 1

A gap analysis compares the current state of compliance against required regulatory standards to identify deficiencies, allowing companies to develop action plans to address these gaps before regulatory submission or inspection.

Answer 2

Labeling requirements include: device identification information, manufacturer details, storage/handling instructions, warnings/precautions, intended use/indications, contraindications, lot/batch number, UDI (where applicable), and instructions for use in appropriate languages.

Answer 3

A UDI (Unique Device Identification) system is a standardized system for identifying medical devices through their distribution and use, using unique numeric or alphanumeric codes that allow for tracking, recalls, and improved supply chain efficiency.

Answer 4

Conformity assessment is the process of verifying that a medical device meets all applicable regulatory requirements before placing it on the EU market. It may involve self-assessment by the manufacturer or assessment by a notified body depending on the device risk class.

Answer 5

A Notified Body is an organization designated by an EU country to assess the conformity of certain products before being placed on the EU market. For higher-risk medical devices, they review technical documentation and quality management systems.

Answer 6

A Declaration of Conformity is a legal document in which the manufacturer declares that their product meets all legal requirements for CE marking, effectively taking responsibility for compliance with applicable EU regulations.

Answer 7

Medical devices in the EU are classified into four classes (I, IIa, IIb, and III) based on their intended purpose and inherent risks. Classification rules consider factors like invasiveness, duration of use, and body contact, with higher classes requiring more rigorous conformity assessment.

Answer 8

FDA classifies medical devices into three classes (I, II, and III) based on the risks they pose. Class I devices present minimal risk and are subject to general controls. Class II devices require special controls and often 510(k) clearance. Class III devices present the highest risk and usually require PMA approval.

Answer 9

A PMA (Premarket Approval) requires clinical evidence demonstrating safety and effectiveness of a Class III device, while a 510(k) demonstrates substantial equivalence to an existing legally marketed device. PMA is more rigorous, costly, and time-consuming.

Answer 10

A Technical File is a comprehensive set of documentation that demonstrates a medical device's compliance with applicable regulatory requirements. It includes design information, risk analysis, verification and validation data, and clinical evaluation.

Answer 11

A PMS Plan under MDR must include methods for collecting and analyzing data, indicators for benefit-risk evaluation, effective management of incidents, complaint handling procedures, methods for communication with authorities, and procedures for implementing corrective actions.

Answer 12

Vigilance specifically refers to the reporting of serious incidents and field safety corrective actions to regulatory authorities, while post-market surveillance is the broader system of actively collecting and analyzing data on quality, performance, and safety of devices throughout their lifecycle.

Answer 13

A Field Safety Corrective Action is an action taken by a manufacturer to reduce the risk of death or serious deterioration in health associated with a medical device already placed on the market. It may include device recalls, modifications, exchange, or destruction.

Answer 14

The PRRC ensures the company complies with MDR requirements including: conformity of devices before release, technical documentation maintenance, post-market surveillance, reporting obligations, and statement verification for investigational devices. They must have appropriate expertise for the role.

Answer 15

A PSUR is a document required under the MDR that summarizes the results and conclusions of post-market surveillance data analysis, including findings from the PMCF, the main results of the PMCF, and rationale for any preventive and corrective actions taken.

Answer 16

Common Specifications are technical specifications adopted by the European Commission that provide a means to comply with legal requirements for specific devices when harmonized standards are insufficient or missing.

Answer 17

Key components include: device description and intended purpose, clinical background/state of the art, clinical literature evaluation, analysis of clinical investigation data, overall risk-benefit profile assessment, conclusions regarding clinical safety and performance, and plans for post-market clinical follow-up.

Answer 18

Key differences include: structure and organization, approach to risk management, design control requirements, supplier management expectations, complaint handling procedures, and documentation requirements. ISO 13485:2016 has become more aligned with FDA QSR in recent revisions.

Answer 19

An MDR is a report submitted to the FDA about adverse events and product problems associated with medical devices. Manufacturers must report when a device may have caused or contributed to a death or serious injury, or has malfunctioned and would likely cause or contribute to death or serious injury if the malfunction recurred.

Answer 20

A CFG is issued by the FDA to foreign governments confirming that products are legally marketed in the US. It helps manufacturers export their devices to countries that require official documentation of FDA regulatory status before allowing importation.

Answer 21

Establishments involved in the production and distribution of medical devices must register with FDA annually, providing details about the facility, the types of operations performed, and a list of all devices manufactured there.

Answer 22

Medical device listing provides the FDA with a catalog of devices commercially distributed in the US. Manufacturers must submit information on each device, including proprietary names, common names, classification, and FDA premarket submission numbers.

Answer 23

A pre-submission meeting allows manufacturers to obtain FDA feedback on planned submissions before formal filing. It helps clarify regulatory pathways, testing requirements, and potential issues, increasing the likelihood of successful market access.

Answer 24

A Design History File contains all records necessary to demonstrate that the design was developed in accordance with the approved design plan and applicable regulatory requirements. It documents the entire design process from conception through commercialization.

Answer 25

A Device Master Record contains the documented procedures and specifications for manufacturing a finished device, including device specifications, production processes, quality assurance procedures, packaging and labeling specifications, and installation/servicing procedures if applicable.

Answer 26

A Device History Record is a compilation of records containing the production history of a finished device, including dates of manufacture, quantities manufactured, acceptance records, labeling, and identification of the primary identification label for each batch or lot.

Answer 27

Factors include whether the modification affects: the device's intended use, technological characteristics, materials, design, energy source, manufacturing processes, or if the modification could significantly affect safety or effectiveness.

Answer 28

Software validation is the confirmation through objective evidence that software specifications conform to user needs and intended uses, and that the requirements implemented through software can be consistently fulfilled. It's required for software used in production or the quality system.

Answer 29

Intended use refers to the objective intent of the manufacturer regarding the use of a product, as determined by the manufacturer's labeling claims, advertising, or statements. It defines what the device does and its therapeutic purpose.

Answer 30

Change Control is a formal process for identifying, documenting, reviewing, approving, and implementing changes to design, manufacturing processes, or quality systems to ensure changes are properly evaluated for potential impacts before implementation.

Answer 31

A supplier quality agreement is a formal document that outlines quality expectations, responsibilities, and communication channels between a medical device manufacturer and its suppliers. It typically covers specifications, change notifications, nonconformances, audits, and record retention.

Answer 32

Internal auditing requirements include: planned audits conducted by trained personnel independent of the area being audited, documented procedures, recording audit findings, timely corrective actions for identified deficiencies, and management review of audit results.

Answer 33

Management Review is a formal, documented review of the quality management system by top management to ensure its continuing suitability, adequacy, and effectiveness. It evaluates quality policies, objectives, audit results, customer feedback, process performance, corrective/preventive actions, and opportunities for improvement.

Answer 34

Verification confirms that specified requirements have been fulfilled (Did we build the device right?). Validation confirms that user needs and intended uses can be consistently fulfilled (Did we build the right device?). Both are required in the design control process.

Answer 35

A comprehensive strategy would include: 1) Conducting a gap analysis between current MDD documentation and MDR requirements, 2) Updating technical documentation to address new requirements such as post-market surveillance and clinical evaluation, 3) Reviewing and updating risk management documentation to align with ISO 14971:2019, 4) Evaluating if reclassification may occur under MDR, 5) Ensuring UDI implementation readiness, 6) Planning for EUDAMED registration, 7) Developing a timeline that considers transition periods and notified body availability, and 8) Training cross-functional teams on new requirements.

Answer 36

I would: 1) Review the proposed change against FDA guidance on when a new 510(k) is needed, 2) Conduct a risk assessment to determine potential impacts on safety and effectiveness, 3) Consult with the cross-functional team to fully understand the change rationale and implications, 4) Document the decision-making process through a formal change assessment, 5) If a new 510(k) is needed, develop a submission plan with Engineering and Quality, 6) If no new submission is needed, ensure proper documentation in the design history file, and 7) Update technical files/documentation as needed.

Answer 37

I would: 1) Create a comprehensive regulatory requirements matrix comparing both jurisdictions, 2) Identify specific areas of difference and analyze their impact, 3) When possible, design the product and documentation to meet the more stringent requirement, 4) Where requirements conflict, develop market-specific approaches while maintaining core compliance, 5) Create a unified technical documentation approach with market-specific modules as needed, 6) Communicate clearly with design teams about dual-market requirements early in development, and 7) Develop verification and validation protocols that satisfy both regulatory frameworks.

Answer 38

I would: 1) Thank the auditor and gather complete details about the finding, 2) Review the applicable regulatory requirement to fully understand the compliance expectation, 3) Assess the scope and impact of the finding, 4) Develop a CAPA plan with clear timelines, 5) Address both the specific finding and evaluate if similar issues exist elsewhere in documentation, 6) Implement corrective actions with cross-functional input, 7) Validate effectiveness of corrections, 8) Communicate progress to the Notified Body within agreed timeframes, and 9) Update quality procedures to prevent recurrence.

Answer 39

Key considerations would include: 1) Understanding Health Canada's Medical Devices Regulations and how our devices would be classified, 2) Determining if our device requires a Medical Device License or if it's exempt, 3) Ensuring our QMS is compliant with ISO 13485:2016 requirements specific to Canada, 4) Preparing for the Medical Device Single Audit Program (MDSAP) if not already participated in, 5) Reviewing labeling requirements including bilingual (English/French) requirements, 6) Assessing if existing clinical data is sufficient for Canadian submissions, 7) Appointing a Canadian Regulatory Representative if the company lacks a physical presence in Canada, and 8) Determining post-market surveillance requirements.

Answer 40

I would: 1) Establish a formal review process for all marketing materials before public release, 2) Create clear guidelines on permissible claims based on cleared/approved indications, 3) Maintain a library of approved claims and supporting evidence, 4) Implement a collaborative review system involving Regulatory, Legal, and Marketing teams, 5) Conduct periodic audits of existing marketing materials, 6) Develop training for marketing staff on promotional constraints, 7) Stay current on enforcement actions related to promotional materials to identify trends, and 8) Create country-specific guidance when promotional requirements differ between markets.

Answer 41

I would: 1) Assemble a cross-functional team including Quality, Engineering, and Clinical experts to evaluate the trend, 2) Review the complaint data against MDR reporting criteria and borderline cases, 3) Consult regulatory guidance documents on similar situations, 4) Document a thorough risk assessment of the trend's potential impact on patient safety, 5) If uncertain about reportability, consider seeking FDA input through a Q-submission, 6) Establish enhanced monitoring of the trend regardless of reporting decision, 7) Implement appropriate corrective actions if needed, and 8) Document the entire decision-making process with rationale in case of future audit.

Answer 42

I would explain that UDI implementation offers significant business benefits beyond compliance: 1) Enhanced supply chain efficiency through standardized product identification, 2) Improved recall management with ability to target specific lots/batches, 3) Better inventory management and reduced carrying costs, 4) More accurate adverse event reporting connecting specific device versions to events, 5) Reduced counterfeiting risk, 6) Enhanced patient safety through accurate device information at point of care, 7) Better data for post-market surveillance and product improvement, and 8) Competitive advantage with customers who prefer suppliers with advanced traceability systems.

Answer 43

I would advise against this approach because: 1) The RTA process only checks for completeness, not substantive review of data, 2) Using RTA for feedback is inefficient and potentially damages the relationship with FDA, 3) A better approach would be a Pre-Submission meeting to get specific feedback on testing protocols and submission strategy, 4) Intentionally submitting incomplete submissions could be viewed as gaming the system, 5) It could actually delay market access compared to a well-prepared submission, and 6) I would suggest we invest in thorough submission preparation with internal expert review instead.

Answer 44

I would: 1) Review FDA's guidance on Human Factors and device usability, 2) Assess if our device has characteristics that typically trigger Human Factors requirements (e.g., complex user interface, critical tasks, use-related risk concerns), 3) Evaluate the use environment and user population for risk factors, 4) Conduct a preliminary usability assessment to identify potential use errors, 5) If a study is needed, develop a protocol identifying critical tasks and potential use errors based on risk analysis, 6) Ensure appropriate participant recruitment representing actual intended users, 7) Document the entire process following FDA's Human Factors guidance, and 8) Use findings to inform design improvements and risk mitigations before submission.

Answer 45

I would: 1) Begin with a comprehensive literature search strategy documenting search terms, databases, and inclusion/exclusion criteria, 2) Ensure state-of-the-art analysis is thorough and up-to-date, 3) Clearly establish equivalence if leveraging data from equivalent devices, noting the MDR's stricter equivalence requirements, 4) Apply critical appraisal methodology to evaluate all clinical data, 5) Ensure risk-benefit analysis is comprehensive and considers alternatives, 6) Identify gaps in clinical evidence and address through PMCF plans, 7) Use qualified experts with documented competency for CER development, and 8) Ensure the CER directly supports the intended purpose and claims made for the device with clear traceability.

Answer 46

I would: 1) Lead a comprehensive review of regulatory submissions to ensure alignment with actual practices, 2) Verify that all commitments made in submissions have been fulfilled and documented, 3) Ensure Design History Files and Technical Documentation are complete and readily accessible, 4) Review complaint handling and MDR reporting for compliance, 5) Conduct mock inspections of regulatory processes and documentation, 6) Prepare subject matter experts on regulatory topics through Q&A sessions, 7) Review previous inspection findings to verify effective CAPA implementation, 8) Ensure establishment registration and device listing information is current, and 9) Coordinate with Quality to ensure all regulatory aspects of the QMS are inspection-ready.

Answer 47

I would: 1) Listen carefully to understand the business rationale behind the desired claims, 2) Clearly explain the regulatory requirements for claim substantiation to the team, 3) Review existing technical documentation and identify specific evidence gaps, 4) Present options: either modify claims to align with available evidence or develop additional evidence to support desired claims, 5) If pursuing additional evidence, help develop a plan for obtaining it (e.g., additional testing, clinical evaluation), 6) Document the assessment and decisions in case of future regulatory scrutiny, 7) Offer to help craft alternative compliant messaging that achieves business goals, and 8) Use this as an educational opportunity to strengthen the team's understanding of regulatory requirements.

Answer 48

My approach includes: 1) Subscribing to regulatory authority communications and industry associations for real-time updates, 2) Participating in industry working groups and standards committees when possible, 3) Establishing a structured process to review and assess regulatory changes for business impact, 4) Creating a regulatory intelligence database to track changes and implementation timelines, 5) Developing cross-functional communication channels to disseminate relevant changes to appropriate teams, 6) Conducting periodic training sessions on significant regulatory developments, 7) Building implementation plans with clear ownership and timelines for required changes, and 8) Monitoring effectiveness of implementation through internal audits and metrics.

Answer 49

I would: 1) Document the discovered change and gather facts about its nature and scope, 2) Assess the potential impact on device safety, performance, and regulatory compliance, 3) Initiate a formal supplier corrective action process through our Quality team, 4) Place potentially affected inventory on hold pending evaluation, 5) Determine if the change affects any regulatory submissions or representations, 6) Conduct appropriate verification/validation to assess if the changed component meets specifications, 7) Evaluate the need for remedial action such as field corrections or regulatory reporting, 8) Review our supplier management system to identify process improvements that would prevent similar occurrences, and 9) Reinforce change notification requirements with all suppliers.

RA Specialist Interview Prep Flashcards

(73 cards)