Start Here: A Quick Snapshot of Your Program

• Tell me briefly which regulatory pathway(s) you are currently targeting for this product? Options: FDA 510(k), FDA De Novo, PMA, EU MDR CE Technical File, Canada medical device licence, Other international markets
• How many active product SKUs or device models are included in the submission scope right now? Options: 1, 2–5, 6–10, More than 10
• Which of the following best describes the principal intended use or indication for the device? Options: Diagnostic, Therapeutic, Monitoring, Surgical adjunct, Combination product, Other
• Describe the stage of product development and whether clinical data already exists for this device. Options: Design complete, clinical data available, Design mature, partial clinical data, Prototype stage, limited clinical data, Early development, no clinical data
• When do you need the first market clearance or CE mark, and is that date fixed? Options: Fixed date within 3 months, Fixed date within 3–6 months, Target within 6–12 months, Flexible / no firm date

Where the Paperwork Really Stands

• If an external reviewer opened your most recent technical file today, how many major gaps would likely cause a non-acceptance? Options: Zero, 1–2, 3–5, More than 5
• List the core technical artifacts you currently have prepared, for example design history file, risk management file, clinical evaluation report. Options: Design history file (DHF), Risk management file (ISO 14971), Clinical evaluation report (CER), Biocompatibility reports, Sterilization validation, Labeling and IFU, Traceability matrices
• How complete is your Device Master Record, on a scale from fully complete to missing key sections? Options: Fully complete, Mostly complete, a few gaps, Significant sections missing, DMR not started
• Who on your team currently owns the clinical evidence and post-market surveillance files? Options: Head of Regulatory, Director of QA/RA, Clinical lead, Product manager, No single owner identified
• Which regulatory standards and guidance documents have you already mapped against for this device? Options: Applicable FDA guidance documents, MDR Annex I/IA requirements, Relevant ISO standards (e.g., 13485, 14971), Harmonized standards, Not mapped yet, Other
• Walk me through the last time a regulator raised a deficiency for a similar device, what happened and how long did remediation take?

Timelines, Budgets, and Who Holds the Keys

• What single deadline or event, if missed, would force you to halt the program or lose access to a market?
• Estimate the number of internal review cycles you plan before submission and the typical signoff roles at each stage. Options: 1 cycle, 2 cycles, 3–4 cycles, More than 4
• Who are the executive sponsors and which procurement or legal approvals could gate contracting?
• If clinical evidence gaps appear during assessment, what budget range could you commit to fund additional studies or consultant work? Options: <$50k, $50k–$150k, $150k–$500k, >$500k, Unsure
• On a scale, how tolerant is leadership of a 6 to 12 month delay in market entry? Options: Very tolerant, Somewhat tolerant, Low tolerance, Not at all tolerant
• Where does timeline authority sit, who can accelerate decisions if an urgent regulator question appears?

What Keeps You Up at Night

• When you imagine the worst regulatory outcome on this submission, what is the single consequence you fear most? Options: Market access loss, Extended delay to launch, Major rework costs, Regulatory sanctions, Other
• Tell me about any prior regulatory rejections or recurring deficiency trends in your portfolio.
• Do you have an active CAPA program linked to design controls and post-market findings? Options: Yes, formal and tracked, Informal process, No formal CAPA program
• Estimate the time required to assemble missing test reports such as biocompatibility or sterilization validation. Options: Less than 2 weeks, 2–4 weeks, 1–3 months, More than 3 months, Not sure
• Name the role that is first notified internally when an agency issues a deficiency letter, and how quickly does remediation begin?
• What would have to change about your current approach for you to feel confident the same issue would not recur?

Competitive Landscape — Who Else Is In The Mix

• List the current alternatives on your evaluation list, including internal teams, an incumbent partner, or other consultancies.
• Point to which option would effectively keep your current approach in place instead of switching. Options: Continue in-house, Renew incumbent contract, Hire a specialist consultancy, Split work between internal and external, Other
• Name one measurable performance outcome your current approach would need to deliver for you not to change providers.
• Has anyone inside proposed solving this entirely with internal headcount, and if so what resource or timeline gaps did they identify? Options: Yes, with gaps identified, Yes, no gaps identified, No internal proposal yet
• Identify the top three risks if you avoid outside help, for example delayed launch, higher remediation cost, or regulatory action. Options: Delayed launch, Higher remediation cost, Incomplete submissions, Regulatory fines or warnings, Loss of market share, Other
• What would need to happen in the next four weeks for you to decide to keep your current approach rather than sign with an external partner?

Operational Readiness and Practical Constraints

• Identify who controls the credentials for API access, raw test reports, or controlled access to your document management system, and can those be granted within ten business days? Options: Yes, can be granted within 10 business days, Yes, but will take longer, No central control identified, Not applicable
• Do you currently have a named document owner for each required artifact, such as DHF, risk file, and CER? Options: Yes, owners assigned, Partially assigned, No owners assigned
• How many full time equivalents and what skillsets can your team allocate to work with external consultants during a peak remediation month? Options: None, 1–2 regulatory specialists, 3–5 mixed QA/RA/clinical, More than 5
• Are there contractual, IP, or confidentiality constraints that would prevent you from sharing complete technical files with an external party? Options: Yes, significant constraints, Minor redactions required, No constraints, Unsure
• Please enumerate the systems that hold your clinical and bench test data, and note whether exports are available in a reviewer-friendly format.
• Is there any pending regulatory change or notified body expectation that could alter submission content in the next six months? Options: Yes, likely, Possible but unclear, No known changes
• Describe the security or privacy approvals required before external access to patient-level clinical data is granted.
• Would inability to provide full exports from your document system within two weeks stop this engagement? Options: Yes, it would stop the engagement, No, we can work around it but timeline increases, No, exports are available

Decision Criteria, Governance, and Next Steps

• Assuming we demonstrate a clear path to first-review acceptance with named milestones, what would stop you from signing a statement of work within 30 days?
• Provide the measurable success criteria that will convince leadership this engagement is delivering value, for example first-review clearance or agency questions resolved within a set timeframe. Options: First-review clearance, Agency Qs resolved within 30 days, Submission accepted by target date, No major deficiencies, Other
• How much of the fee schedule is flexible if milestones are explicitly tied to acceptance criteria? Options: Fee is fixed, Partial milestone flexibility, Significant flexibility, Undecided
• Provide the roles that must sign the SOW, approve the budget, and join the governance cadence for work to start.
• Are there procurement or legal steps that normally add six weeks or more to contracting in your organization? Options: Yes, typically adds >6 weeks, Sometimes adds delay, No, contracting is fast
• What single internal veto or constraint could stop this deal even if everything else aligns?
• Within what timeframe would you want a pilot or assessment working session to begin if terms were agreed next week? Options: Within 1 week, Within 2 weeks, Within 1 month, More than 1 month
• Please enumerate the deliverables you would insist on seeing in the first 30 days to feel the engagement is on track.
• Finally, who should be our single point of contact on your side and do they have authority to make day-to-day decisions? Options: Has full day-to-day authority, Has partial authority, needs exec signoff for some items, No single point identified yet

• Engagement Assumptions and Scope Confirmation
• Technical File Gap Diagnostic
• Gap Prioritization and Remediation Backlog
• Remediation Plan Validation and Sign-Off

• Collect any additional technical input required to finalize effort estimates for complex remediation tasks.
• A complete, section-level gap list is produced with references to existing evidence and a severity score for each gap.
• A list of specific missing data items or clarifications is captured to enable remediation work.
• Agreement on the assessment template and scoring method for use in subsequent sessions.
• Populate the shared gap tracker with the documented gaps, evidence links, and preliminary severity scores.
• Provide the outstanding documents or data items listed as 'missing' in the session for evidence review.
• List any technical or standards interpretations needed for ambiguous gaps for follow-up.
• Review summary of high severity gaps
• A prioritized remediation backlog is accepted, with each item having a defined task, severity, estimated effort, and owner.
• Critical-path items that affect submission timelines are identified and flagged for immediate action.
• Acceptance criteria and required evidence for each remediation task are documented.
• Publish the prioritized remediation backlog with task descriptions, severity, effort estimates, and recorded owners.
• Schedule focused follow-up work sessions for critical-path remediation items identified as high priority.
• Present consolidated remediation plan and timeline
• Formal sign-off on the remediation plan with confirmed owner commitments and milestone dates.
• A governance cadence and escalation path for remediation progress are documented and agreed.
• A clear set of immediate next steps to begin remediation execution is defined.
• Record formal sign-off on the remediation plan and distribute the signed plan to stakeholders.
• Create the first progress report template and schedule the recurring governance meetings.
• Initiate the highest priority remediation tasks per the agreed schedule and report status at the first governance meeting.
• Confirm devices and submission objectives
• Scope, device list, target regulatory pathways, and document inventory are confirmed and recorded.
• Access method for each required document repository is validated or an action assigned to enable access.
• Success criteria and target dates for the assessment phase are agreed and documented.
• Provide a finalized list of devices and target submission pathways, including any device variants to be included in the assessment.
• Grant read access to the agreed document repositories or deliver a zipped document package to the working team.
• Confirm the single point of contact for document questions and evidence clarification.
• Review mapping framework and assessment template
• Define applicable regulations and standards
• Walk through each technical-file section
• Review owner commitments and reviewer checks
• Prioritize gaps by regulatory risk, timeline sensitivity, and remediation complexity
• Score gaps by regulatory impact and evidence gap type
• Agree governance and reporting cadence
• Define remediation tasks and estimate effort
• Inventory required technical documents
• Assign named owners and handoff criteria
• Sign-off and next steps to begin execution
• Confirm success criteria and timelines
• Capture unresolved data or clarification needs
• Data access and confidentiality checklist

• Prepare 510(k) submission dossier
• Prepare PMA application dossier
• Compile EU MDR technical documentation
• Draft Clinical Evaluation Report (CER)
• Draft Usability / Human Factors Validation Report
• Develop Risk Management File (ISO 14971)
• Assemble Design History File (DHF) documentation
• Respond to FDA deficiency letters and remediation
• Prepare pre-submission meeting package and meeting support
• Prepare Post‑Market Surveillance Report and PSUR
• Prepare Instructions for Use and regulatory labeling
• Compile biocompatibility and bench test evidence binder
• Prepare international market submission dossiers

Prepare 510(k) submission dossier

• Which FDA 510(k) pathway are you targeting for this device (traditional, abbreviated, special, or eSTAR)? Options: Traditional 510(k), Abbreviated 510(k), Special 510(k), eSTAR / Electronic
• Do you have a predicate device and, if so, provide the predicate 510(k) number and key equivalence claims?
• Which device classification and product code apply to your device per 21 CFR and FDA guidance? Options: Class I, Class II, Class III, Unknown
• Who on your team will own submission sign-off for the device description, labeling, and verification/validation reports?
• By when do you need 510(k) submission readiness (target filing date)? Options: Within 1 month, 1-3 months, 3-6 months, 6+ months
• What acceptance criteria will confirm the 510(k) dossier is complete for FDA filing (e.g., eCopy/eSTAR checks, device description, test traceability)?

Prepare PMA application dossier

• Which regulatory basis requires a PMA for your device (novel implantable device, Class III, life-sustaining, or other)? Options: Class III, Implantable, Life-sustaining/critical, Other / Unknown
• Do you have pivotal clinical data or an investigational device exemption (IDE) study available to support the PMA? Options: Pivotal IDE data available, Ongoing IDE, Plan to generate data, No clinical data
• Which manufacturing controls and device master record elements are in place to support PMA CMC (chemistry, manufacturing and controls) sections?
• Who will be responsible for preparing the PMA technical sections: clinical summary, nonclinical bench testing, biocompatibility, and labeling?
• How long is your internal review and QA cycle for PMA exhibits (e.g., clinical reports, manufacturing validation)? Options: <2 weeks, 2-4 weeks, 4-8 weeks, 8+ weeks
• What acceptance criteria will demonstrate the PMA submission meets FDA format and content expectations (e.g., complete clinical summaries, signed declarations, validated datasets)?

Compile EU MDR technical documentation

• Which EU MDR route and classification apply to your device under MDR rules (Class I, IIa, IIb, III) and do you require a Notified Body full assessment? Options: Class I (no NB), Class IIa, Class IIb, Class III
• Which Annexes of MDR (Annex II technical documentation, Annex III EU declaration of conformity) are you preparing and who will register the device in EUDAMED? Options: Annex II, Annex III, Both, Unsure
• Do you have a clinical evaluation report (CER) consistent with MDR Annex XIV and relevant MEDDEV/MDR guidance to justify safety and performance? Options: CER available, CER draft, CER required
• Indicate existing post-market surveillance (PMS) documentation and planned PMCF (post-market clinical follow-up) activities required by MDR Article 61.
• Provide the target Notified Body submission timeline and expected review milestones (initial review, technical documentation audit, conformity assessment certificate date).
• What acceptance criteria will confirm the EU MDR technical file is complete for Notified Body review (e.g., Annex II checklist, clinical justification, risk management linkage)?

Draft Clinical Evaluation Report (CER)

• Which clinical evidence sources will your CER rely on: published literature, own clinical investigations, or equivalence to devices on the market? Options: Published literature, Own clinical data, Equivalence / Predicate data, Combination
• Describe the time window and search strategy for the literature review (databases, search terms, date range) that will support the CER.
• Which clinical endpoints or performance metrics will be used to demonstrate clinical benefit or safety in the CER?
• Who will perform the evidence appraisal and critical evaluation for clinical relevance, bias, and applicability to your device?
• Specify whether you need a gap analysis mapping clinical data to MDR Annex XIV / MEDDEV expectations and a remediation plan for missing data. Options: Gap analysis and plan required, Gap analysis only, Not required / already complete
• Identify any planned PMCF studies or registries that should be referenced in the CER and provide their timelines.

Draft Usability / Human Factors Validation Report

• Which usability standard or guidance applies (IEC 62366-1, FDA human factors guidance) for your device's validation testing? Options: IEC 62366-1, FDA HF Guidance, Both, Other / Unsure
• Do you have formative usability data and a finalized user interface to support summative (validation) testing? Options: Formative data available, Formative in progress, No formative data
• List the critical tasks and user populations to be included in human factors validation (e.g., clinicians in OR, home users, technicians).
• Specify the pass/fail criteria for summative usability testing such as task success rates, critical use-error thresholds, and remediation plans.
• Who will recruit representative users and run validation sessions, and do you require test-lab facilities or remote/virtual testing? Options: We recruit and run, We need tester support, Remote testing preferred, Lab testing preferred
• Indicate whether usability report deliverables should include raw session data, videos, and a training-needs assessment. Options: Full raw data and videos, Summary reports only, Summary + exemplar clips

Develop Risk Management File (ISO 14971)

• Which risk management activities are already complete: hazard identification, risk estimation, risk control measures, or residual risk evaluation? Options: Hazard ID, Risk estimation, Risk controls defined, Residual risk evaluated, None
• Which probability and severity matrix or risk acceptability criteria do you use to assess residual risk (attach or name the document)?
• Who will own linking the risk management file to verification/validation evidence and labeling (traceability matrix owner)?
• Specify how frequently you require the risk management file to be reviewed and updated during development and post-market surveillance. Options: At major design review, Quarterly, Annually, As-needed
• Identify any known hazardous situations or use-related risks uncovered in complaints or vigilance data that must be addressed in the RMF.
• Are there specific ISO 14971 outputs you require (risk management plan, risk analysis, benefit-risk evaluation, risk traceability matrix)? Options: Plan, Analysis, Benefit-risk evaluation, Traceability matrix

Assemble Design History File (DHF) documentation

• Which DHF artifacts are complete: design inputs, design outputs, verification reports, validation reports, design reviews, or change history? Options: Design inputs, Design outputs, Verification, Validation, Design reviews, Change history
• Do you have software lifecycle documentation for embedded software per IEC 62304 if the device contains software? Options: IEC 62304-compliant, Partially documented, No software / not applicable
• Provide the bill of materials (BOM) and supplier qualification status for critical components that must be included in the DHF.
• Who will serve as the DHF custodian and provide signed design review minutes required by 21 CFR 820.30?
• Specify the traceability format you prefer (matrix linking user needs → design inputs → verification/validation) for inclusion in the DHF. Options: Traceability matrix (spreadsheet), Traceability matrix (document), Other
• Indicate any outstanding verification or validation tests that must be completed before DHF close and provide estimated completion dates.

Respond to FDA deficiency letters and remediation

• Do you have an existing FDA deficiency letter or complete response to an FDA RTA/Rejection on file (provide letter date and reference)? Options: Deficiency letter on file, Preparing response, No deficiency letter
• Which deficiency categories does the FDA letter cite: clinical evidence, bench testing, labeling, manufacturing controls, or other? Options: Clinical evidence, Bench testing, Labeling, Manufacturing controls, Other
• Who will be the point person for FDA correspondence and who signs the formal response package?
• Estimate the timeline you can commit to for remediation tasks such as additional bench testing, new clinical analysis, or labeling revisions. Options: <2 weeks, 2-6 weeks, 6-12 weeks, 12+ weeks
• Describe any constrained dependencies required for remediation (e.g., lab availability, patient recruitment, supplier lead times).
• Indicate whether you want us to prepare the complete FDA response package and cover letter, or provide review-only support. Options: Prepare full response package, Review-only / advisory

Prepare pre-submission meeting package and meeting support

• Which meeting type are you requesting: Q-Submission (Q-Sub), Pre-Sub brief, or Type A/B/C meeting with the agency? Options: Q-Sub, Pre-Sub briefing, Type A meeting, Type B/C meeting
• List the specific questions you want the agency to address in the meeting package (clinical endpoints, regulatory pathway, acceptance of equivalence).
• Who will present during the meeting and which experts (clinical, manufacturing, statistical) should attend or be available?
• Provide desired timing for draft package submission to the agency and internal review checkpoints prior to filing.
• Indicate whether you require pre-meeting mock Q&A and a finalized briefing document formatted to agency templates. Options: Mock Q&A + briefing doc, Briefing doc only, No mock required
• Specify any confidentiality or embargo concerns for presenting unpublished clinical data during the meeting. Options: Yes, No

Prepare Post‑Market Surveillance Report and PSUR

• Which post-market data sources will feed the PSUR: complaint database, vigilance reports, registry data, or published studies? Options: Complaints, Vigilance, Registry, Published studies, All
• What PSUR periodicity do you need (annual, biennial) to satisfy EU MDR or other regional requirements? Options: Annual, Biennial, As required by NB/regulator
• Identify signal detection thresholds or KPIs you want included (e.g., complaint rate per device years, SAE rate thresholds).
• Who will provide the raw safety datasets and complaint line listings for PSUR compilation?
• Specify whether the PSUR should include trend analysis, root-cause assessments, and recommended corrective actions tied to the risk file. Options: Trend + RCA + CAPA recommendations, Trend analysis only, Summary only
• Are there country-specific vigilance formats or timelines we must follow (e.g., 15-day reports for the US, MDR timelines for EU)? Options: Yes - will provide list, No / standard reporting

• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Fee Schedule and Payment Terms
• Governance and Review Cadence
• Data Access Authorization & Security
• Data Processing Agreement (DPA) / HIPAA BAA
• Acceptance Criteria and Sign-Off Checklist
• Change Order Agreement
• Confidentiality and Non-Disclosure Agreement (NDA)

• Confirm final submission package completeness against SOW deliverable checklist
• Obtain seller QA checklist sign-off
• Receive buyer acceptance signature on Submission Acceptance Form
• Record agency acknowledgement or submission reference
• Verify closure or formal risk acceptance of critical/high remediation items
• Confirm designated agency communications and escalation contacts
• Create and verify read-only archive snapshot and rollback point of final submission
• Complete data-access provisioning/deprovisioning per SOW
• Obtain billing authorization to trigger invoice
• Handover post‑market responsibilities and closeout documentation

• Initial Post-Market Health Check (weeks 1-4)
• First Compliance Measurement (weeks 4-10)
• 90-Day Post-Market Remediation Review (around day 90)
• Quarterly Operational Compliance Review
• Annual Regulatory Outcomes Review

• Publish the quarter's compliance dashboard and the prioritized backlog for the next 90 days.
• Re-confirm scope and success criteria
• Execute the incumbent decommissioning checklist or document the read-only retention plan and archive status.
• Initiate agreed escalations for items not meeting closure criteria with target completion dates.
• Operational metrics dashboard
• Ensure on-time report filing and change-control SLA compliance rates meet the agreed operational thresholds or have remediation plans.
• Agree priority list for backlog items to be addressed in the next quarter with target completion windows.
• Identify any inspection risks or upcoming deadlines requiring immediate mitigation.
• Enable data access for the defined reviewers to allow reporting in the next measurement meeting.
• Assign verification steps for high-risk CAPAs with target close dates.
• Schedule any required external submissions or notifications to meet upcoming regulatory deadlines.
• Year in review of regulatory interactions
• Document the annual count of regulatory interactions that resulted in formal findings and the average time to close CAPAs.
• Agree the top 3 compliance priorities and any required resource or tooling actions for the coming year.
• Ensure a clear schedule of mandatory reports, audits, and surveillance activities for the next 12 months is in place.
• Publish the annual regulatory outcomes summary and the agreed compliance roadmap for the next year.
• Create an audit-readiness checklist for high-risk product lines with assigned completion dates.
• Schedule quarterly checkpoints to monitor progress against the annual priorities.
• Confirm post-market intake, vigilance, and change-control workflows are instrumented and producing expected logs.
• Identify and document top 3 deployment blockers with resolution dates.
• Agree owners and due dates for immediate remediation actions to restore full monitoring coverage.
• Publish the deployment validation checklist and remaining defect list with resolution dates.
• Document temporary manual workarounds for any intake gaps until automation is fixed.
• Present first measurement data
• Establish whether open surveillance issue count and on-time report submission percentage are trending toward the targets.
• Document 3 corrective actions with completion dates that address the highest-impact root causes.
• Confirm evidence requirements and data sources for the 90-day remediation review.
• Deliver a remediation task list with measurable acceptance criteria and deadlines.
• Provide the raw data extracts and dashboards used to generate the metrics for auditability.
• Create a short escalation path for any regulatory-action items requiring immediate attention.
• Restate committed remediation items and acceptance criteria
• Document the percent of high-priority remediation tasks closed and the median time-to-resolution for regulatory actions since go-live.
• Confirm the incumbent system is either decommissioned or retained read-only and that data archival tasks are scheduled or complete.
• Agree clear escalations with deadlines for any remediation items that remain open past the 90-day window.
• Publish the 90-day remediation report with evidence links and outstanding item list.
• CAPA and complaint triage overview
• CAPA and long-term remediation performance
• Present remediation closure status and evidence
• Root-cause diagnosis for any gaps
• Deployment and system validation
• Enhancement and change-control backlog
• Incumbent system wind-down checkpoint
• Change-control and product-enhancement impact
• Agree corrective actions and timelines
• Early adoption and operational signals
• Blockers and open issues
• Compliance priorities and resourcing for next year
• Confirm readiness for 90-day remediation review
• Escalations and conditional actions
• Operational risks and near-term regulatory calendar
• Immediate remediation actions