Start Here: The One Thing You Need Us to Know

• In one sentence, what is the single regulatory outcome you most urgently need from this project?
• What is the device type and its current regulatory classification? Options: Class I (low risk), Class II (moderate risk), Class III (high risk), Software as a Medical Device (SaMD), Not sure / need help classifying
• Which markets are you actively targeting with this submission? Options: United States (FDA), European Union (MDR/IVDR), Canada (Health Canada), Japan (PMDA), Other international markets, Multiple of the above
• Why now—what event or deadline triggered you to start this engagement? Options: New product ready for submission, EU MDR recertification deadline, FDA deficiency letter, Investor/commercial deadline, Other
• How confident are you in the completeness of your current submission-ready package? Options: Very confident, Somewhat confident, Unsure, Not confident at all

What Would a Six‑Month Delay Actually Cost You?

• If this submission were delayed by six months, what concrete business and regulatory consequences would you face?
• Which of the following impacts would be most damaging if delayed (pick the top two)? Options: Revenue loss, Contract penalties, Loss of distribution/market access, Clinical trial delays, Investor confidence, Patient access/health impact
• Have you ever experienced a multi‑month delay before? If yes, what caused it and how long did it take to recover? Options: Yes—regulatory deficiencies, Yes—testing failures, Yes—resource constraints, No, not previously
• How does the leadership team feel about the risk of delay—are they anxious, resigned, or confident? Options: Very anxious, Somewhat concerned, Resigned/used to it, Confident we can handle it
• On a scale from 1–5, how critical is meeting the current target date for commercial or contractual reasons? Options: 1, 2, 3, 4, 5

Who Holds the Keys — and Who’s Left Out?

• Who are the decision‑makers that must sign off on regulatory strategy and final submissions? Options: VP Regulatory Affairs, Chief Quality Officer, CEO, Head of R&D, External legal counsel, Not sure / multiple
• Which functional owners are typically consulted late (and cause hold‑ups)—QA, R&D, clinical, manufacturing, others? Options: Quality Assurance, R&D/Engineering, Clinical/Medical Affairs, Manufacturing/Operations, Regulatory Affairs, Other
• Who will be our primary point of contact day‑to‑day, and how much decision authority do they have? Options: VP Regulatory (full authority), Director-level (approval needed higher up), Program Manager (coordination only), External consultant/fiduciary, TBD
• How aligned are those stakeholders on timelines, acceptable risk, and required evidence—fully aligned, some disagreement, or deeply divided? Options: Fully aligned, Some disagreements, Significant conflict, No one has discussed alignment
• When decisions stall, what usually causes the blockage—insufficient data, budget fights, conflicting priorities, or lack of reviewer perspective? Options: Insufficient data, Budget constraints, Competing priorities, No reviewer-side perspective, Other

Where the Paperwork Trips You Up

• Which specific document or evidence do you most fear will be called out by a regulator? Options: Design History File (DHF), Risk Management Report (ISO 14971), Verification & Validation reports, Clinical evidence / literature, Labeling and Instructions for Use, Not sure
• Which of these areas currently have clear gaps that would delay submission? Options: Traceability and DHF, Biocompatibility/testing, Software verification, Clinical data / literature gap, Human factors/usability, Cybersecurity documentation
• Do you have recent test reports and device history readily accessible for reviewers to inspect? Options: All reports current and accessible, Most reports available but scattered, Significant reports missing, Not sure / need inventory
• When you run a gap assessment today, how long does it take to produce an actionable remediation plan? Options: <2 weeks, 2–4 weeks, 1–3 months, Longer than 3 months, We haven’t run one recently
• Who on your team owns document quality and reviewer‑level storytelling (e.g., former-examiner review, structured arguments)?

If Reviewers Could Speak: The Unsaid Expectations

• What recurring comments or deficiency types have you seen from regulators in past submissions? Options: Insufficient clinical justification, Gaps in V&V, Unclear risk controls, Labeling inconsistencies, Inadequate traceability, No consistent pattern
• Have you previously received an FDA deficiency letter or Notified Body nonconformity—what was the root cause and how long to resolve? Options: FDA deficiency letter, Notified Body nonconformity, Both, Never received one, Prefer to describe
• How often do you conduct an internal 'reviewer perspective' pass before filing? Options: Every submission, Only for high-risk filings, Rarely, Never
• Tell us about a submission that cleared quickly—what specifically made it successful?
• Which reviewer-side practices would you be most open to adopting (pick all that appeal)? Options: Pre-submission briefing documents, Red-team reviewer pass, Structured summary tables, Reviewer-style traceability maps, Dedicated former-examiner reviewer

What Winning Actually Looks Like

• If this engagement results in a first-cycle clearance/approval, what measurable outcomes change for you in the next 12 months?
• Which of the following are required for you to call this project a success? Options: First-cycle regulatory clearance, No major post-market actions, On-time commercial launch, Budget targets met, Internal process improvements realized
• What are your non-negotiable acceptance criteria for deliverables (e.g., evidence level, signing authority, or documentation standard)?
• How will your executive team measure and celebrate success—revenue, market share, risk reduction, or something else? Options: Revenue, Market access/penetration, Regulatory risk reduction, Investor milestones, Patient reach/impact
• Who needs to be present or briefed at key milestone gates for you to consider the project on track? Options: CEO, VP Regulatory, Head of QA, CFO, Commercial Head, Other

Tradeoffs: Time, Scope, Budget — Which Do You Give Up?

• If you had to trade one—time, scope, or budget—which would you be most willing to compromise on and why? Options: Time, Scope, Budget, None—must keep all
• What internal budget range have you allocated (or expect to allocate) for external regulatory support on this submission? Options: <$50k, $50k–$150k, $150k–$500k, >$500k, Undecided / need proposal
• Would you consider a phased engagement (strategy → docs → submission) to accelerate high‑risk items while deferring lower‑risk work? Options: Yes—phased is preferred, Maybe—need details, No—must be end-to-end
• How tolerant is leadership of contingency spending if unexpected gaps appear? Options: High—we can flex, Moderate—limited reserve, Low—needs approval each time
• What would make you comfortable increasing budget to avoid a high‑probability delay?

Let’s Talk Execution — Who Will Do What, and When?

• What keeps projects slipping in the handoff from strategy to execution at your company? Options: Unclear ownership, Resource overload, Poor timelines, Lack of reviewer insight, Competing priorities
• Which delivery model do you prefer for external support? Options: Full-service engagement (we hand off everything), Augment internal team (collaborative), Advisory only (periodic review), On-call expert reviewers
• Who will be responsible for providing artifacts and arranging tests—internal RA, QA, R&D, or a mix? Options: Regulatory Affairs, Quality Assurance, R&D/Engineering, Manufacturing, Combination / Program Manager
• What cadence of governance and updates do you expect (weekly touchpoint, biweekly steering, monthly executive review)? Options: Weekly working sessions, Biweekly steering, Monthly executive review, Ad hoc as needed
• Are there systems or platforms we must use to share documents (e.g., your QMS, VDR, or preferred project tool)? If yes, please name them.

Final Check: Red Flags and Next Steps

• Before we proceed, what is the single biggest unknown that would make you pause on this engagement?
• Which regulatory changes or external forces are you most worried could impact this submission while we work on it? Options: FDA guidance updates, EU MDR/IVDR interpretations, Standards changes (ISO), Reimbursement/payer shifts, Competitor actions, Other
• How soon would you be ready to proceed if we presented a clear plan and fixed deliverables? Options: Immediately, Within 2 weeks, Within 1 month, Longer—requires approvals
• Would you authorize a rapid gap assessment to give us a candid first-pass view of submission risk and a remediation estimate? Options: Yes—authorize now, Need internal approval, Not at this time
• Who should receive our summary findings and proposed next steps once the gap assessment is complete? Options: VP Regulatory, Head of QA, CEO, Program Lead, Other

Start Here: Where You Really Stand

• Briefly describe the device(s) or product family this engagement should cover (intended use, device class, and key features).
• Which regulatory markets and pathways are you actively pursuing right now? Options: FDA 510(k), PMA, De Novo, EU MDR (CE technical file), UKCA, Canada (MDR), Other
• What is the single current submission or activity stage for your priority product? Options: Gap assessment/strategy, Documentation development, Verification/validation testing, Submission preparation, Responding to agency questions, Post-market activities
• How many active submissions or regulatory threads are you managing concurrently for this product family? Options: 1, 2–3, 4–6, 7–10, More than 10
• Who on your team will be the primary day-to-day contact for regulatory questions and deliverables?
• How long has your current regulatory strategy for this product been in place? Options: Less than 1 month, 1–3 months, 3–6 months, 6–12 months, Over a year

What's Keeping You Up at Night?

• If a regulator issued a deficiency letter tomorrow, what's the first shortcoming you suspect they'd call out?
• Which of these problems have shown up in past reviews or audits for your products? Options: Insufficient clinical evidence, Incomplete risk management, Gaps in verification/validation, Poor traceability, Labeling inconsistencies, Sterilization/biocompatibility gaps, Cybersecurity concerns, Other
• How many prior submissions for this product family received major objections, and what was the typical cause? Options: None, 1, 2–3, 4 or more
• When those issues happened, how long did it typically take to recover and resubmit? Options: Less than 1 month, 1–3 months, 3–6 months, 6–12 months, More than 12 months
• How does the risk of another rejection affect your launch timing and commercial plans (quantify if possible)? Options: Minor impact, Moderate delay (weeks), Significant delay (months), Major market access risk
• Tell us about the emotional or political pressure internally when a submission stalls—who feels it most and how does it manifest?

Which Single Failure Would Break the Chain?

• If you had to name one weakest link today (process, person, document, or supplier), what is it and why?
• How mature are your SOPs and change-control processes for submission-related activities? Options: Fully mature and followed, Mostly defined but inconsistently followed, Partially defined, Minimal or ad hoc
• Where do delays most often originate: internal reviewers, testing vendors, suppliers, or agency back-and-forth? Options: Internal reviewers, Testing vendors, Component suppliers, Regulatory agency interactions, Other
• Do you maintain a shared traceability matrix that ties requirements → verification → risk controls → labeling? If yes, how current is it? Options: Yes — up to date, Yes — but outdated, No — partial, No — none
• How long does it typically take your team to implement a corrective action once an issue is identified? Options: Less than 2 weeks, 2–6 weeks, 6–12 weeks, More than 12 weeks

Can You Produce the Papers in Two Weeks?

• Which of these key documents could you provide to a reviewer within two weeks in reviewer-ready form? Options: Design History File (DHF), Risk Management File (ISO 14971), Verification & Validation protocols and reports, Clinical evaluation/report, Technical file / Design dossier, Labeling and IFU, Traceability matrix, Post-market surveillance plan, Cybersecurity documentation, None of the above
• For each of the following documents, select the status that best fits your current state: Design History File. Options: Up-to-date and reviewer-ready, Exists but needs revision, Partial or fragmented, Missing
• Risk Management File status. Options: Up-to-date and reviewer-ready, Exists but needs revision, Partial or fragmented, Missing
• Verification & Validation evidence status (test plans, protocols, reports). Options: Comprehensive and reviewer-ready, Some tests missing or incomplete, Mostly missing, No formal V&V documentation
• Clinical evidence / clinical evaluation status. Options: Robust and referenced, Limited but usable, Needs literature/analysis, None
• Labeling, IFU, and marketing claims—are they aligned with your evidence and intended indications? Options: Fully aligned, Minor inconsistencies, Significant inconsistencies, Not aligned or outdated
• If any document is 'missing' or 'partial', which one would cause the biggest reviewer concern and why?

Who Will Take the Heat?

• If regulators escalate an issue, whose role in your organization would be held accountable and why?
• Which stakeholders must sign off on submissions and who can approve rapid changes if needed? Options: VP Regulatory, Director Quality, Head of R&D, Chief Medical Officer, CEO/President, External consultant/SME
• Do you have external consultants, testing labs, or notified bodies already engaged? List them and their responsibilities.
• How clear are roles and ownership between regulatory, QA, R&D, and clinical teams when a submission needs rapid remediation? Options: Very clear, Somewhat clear, Ambiguous, Conflicting responsibilities
• When conflicts arise about submission content, what is your escalation path and how long does resolution usually take?

Which Deadline Would Stop Everything?

• Which upcoming regulatory deadline poses the largest risk to your market access or launch plans? Options: EU MDR recertification, FDA response deadline, Clinical trial reporting, Notified body audit, Third-party supplier certification, Other
• How firm are those external timelines (agency windows, notified body schedules, clinical site availability)? Options: Very firm — low flexibility, Somewhat flexible, Flexible, Unknown
• What internal milestones must be hit to meet that external deadline (e.g., finalize V&V, complete clinical analysis)?
• Do you have resource coverage (people, budget, testing capacity) to meet the critical milestones in the next 90 days? Options: Yes — fully funded and staffed, Partially — gaps exist, No — significant gaps, Unsure
• If a deadline slips, what is the realistic delay impact on launch or market access (weeks/months/market loss)? Options: Minor (weeks), Moderate (1–3 months), Severe (3–12 months), Critical market loss
• Have you budgeted for contingency actions (e.g., additional testing, third-party reviewer time) if issues arise? Options: Yes — contingency budget exists, Partially budgeted, No contingency budget, Unsure

If Reviewers Signed Off First Time, What Changed?

• Imagine the reviewer accepted your submission on the first cycle—what would have been the single biggest change compared to today?
• What specific acceptance criteria or reviewer concerns would you want us to guarantee we address?
• Which measurable signals would tell you the submission is ready (e.g., complete traceability, 100% V&V coverage, clinical evidence threshold)?
• Who needs to explicitly approve the final package before filing (list names/titles)?
• Do you have prior submissions or reference packages we should model after? If yes, how similar are they? Options: Very similar, Somewhat similar, Not similar, No prior packages
• What would give your executive team confidence to greenlight a first-cycle filing? Options: Clear acceptance criteria, Historical reviewer success, Third-party review, Defined remediation plan, Other

What Can We Fix in 30 Days to Reduce Risk?

• If we focus on one high-impact mitigation over the next 30 days, what should it be (document, test, stakeholder alignment, or other)? Options: Complete gap assessment and plan, Stabilize traceability matrix, Finalize critical V&V test, Update risk management file, Align stakeholders and signoffs, Other
• How quickly can your team make subject-matter experts and documents available for an urgent gap assessment? Options: Immediately, Within 1 week, Within 2–4 weeks, Longer than 4 weeks
• Which of these quick actions would you be willing to commit to in the next month to lower failure risk? Options: Allocate SME hours, Fund expedited tests, Engage external reviewer, Freeze scope/claims, Other
• What communication cadence works best for rapid alignment (daily standup, twice-weekly sync, weekly checkpoint)? Options: Daily standup, Twice-weekly, Weekly, Biweekly, Ad hoc as needed
• Who should we include in a 30-day rapid-response group (names/titles or functions)?

Getting Comfortable Together

• Tell us the product name, primary intended use, and the exact markets you plan to submit to first (e.g., FDA 510(k), EU MDR, Health Canada).
• Which regulatory pathway(s) are you targeting for this submission? Options: FDA 510(k), De Novo, PMA, EU MDR (CE), UKCA, Health Canada, Other (please specify)
• How would you describe the device risk/classification today? Options: Class I / Low risk, Class II / Moderate risk, Class III / High risk, Not yet classified / unknown
• Who on your team will be our primary contact for technical questions, and who is the executive sponsor we should keep informed?
• Roughly how soon do you need the filing to be submitted or a clearance decision reached? Options: Immediately (within 2–4 weeks), In 1–2 months, In 3–6 months, Longer than 6 months / planning stage

If We Filed Today, What Would Break?

• Imagine we hit 'submit' this afternoon — what critical item(s) would cause an immediate reject or major deficiency? Options: Missing test reports, Incomplete risk management file, No traceable design control, Unapproved labeling, No clinical evidence, Other (please describe)
• Which specific test reports or protocols are incomplete, missing, or still in draft form? Options: Bench/functional testing, Performance/verification, Biocompatibility, Electrical safety (IEC), Software verification/validation, Sterility/packaging, Usability/HFE, Clinical study reports, None missing / all complete
• For any missing or draft items above, how long would it take to finalize them if prioritized? Options: <2 weeks, 2–4 weeks, 1–2 months, 2–3 months, Longer than 3 months, Don't know
• Have you ever received a regulatory deficiency or rejection on a related device or submission? If yes, briefly describe what triggered it. Options: Yes — technical/testing issues, Yes — labeling/claims, Yes — clinical evidence, Yes — quality system gaps, No
• Which of these would you say is the single biggest risk to a first-cycle approval for this submission? Options: Insufficient evidence (testing/clinical), Poor traceability between design and verification, Unclear intended use/claims, Quality system documentation gaps, Regulatory pathway misalignment, Other

Who’s Holding the Keys — Access, Owners, and Backups

• Who currently holds primary custody of the device data, test artifacts, and design history (names and roles)?
• If that person were unavailable for two weeks, what would happen to review or approval tasks tied to the submission? Options: Work pauses entirely, Delegated to a backup but with delay, We have documented backups and work continues, We'd need support from outside consultants
• Do you have account-level access (or intent to grant it) to the submission portals we’ll need (e.g., FDA ESG, EU Notified Body portals)? Options: Yes — already set up, In progress — partial access, No — will need help setting up, Not applicable / vendor will submit
• List the named owners for these domains and whether they are decision-makers or contributors: Regulatory, Quality, R&D/Engineering, Clinical, Manufacturing, Supply Chain.
• How mature is your internal RACI for submission tasks (file owner, reviewer, approver)? Options: Well-defined and used, Defined but inconsistently followed, Informal / ad hoc, None exists

Paper Trail or Wild West — Documentation, Traceability, and Version Control

• How confident are you that the documents we plan to include tell a single, defensible story from risk to verification to labeling? Options: Very confident, Somewhat confident, Unsure / needs work, Not confident
• Which of the following documentation artifacts exist in final, approved form and are traceable to design inputs/outputs? Options: Design History File (DHF), Risk Management File (ISO 14971), Traceability Matrix, Clinical Evaluation/Reports, Verification & Validation protocols and reports, Labeling and IFU, Change control records, None of the above
• If you use a document control system (e.g., QMS), name it and state whether external consultant accounts can be provisioned for read-only access.
• Are there known inconsistencies between versions of documents (e.g., specs vs. test protocols vs. labeling)? If so, pick the areas where inconsistencies are most likely. Options: Intended use/indications, Performance specs, Acceptance criteria, Test methods, Labeling/IFU, None
• Would you be willing to let our former-examiner reviewers run a gap checklist against one key file (e.g., DHF or RMF) before we finalize the submission? Options: Yes — preferred, Maybe — need to confirm internally, No — not at this stage

Where Timing Hides the Problems — Deadlines, Dependencies, and Lead Times

• What non-negotiable deadlines are driving this submission (e.g., product launch, contract milestones, regulatory transition dates)?
• Which dependencies are most at risk of slipping and would derail your timeline if delayed? Options: Third-party test labs, Supplier documents/certificates, Clinical site enrollment, Notified Body slots, Internal resource availability, Other
• How often do you update your internal timeline, and who owns that cadence? Options: Weekly, Bi-weekly, Monthly, Ad hoc / as needed
• When a critical dependency slips, what is your usual mitigation — accelerate, scope down, push deadline, or add external resources? Options: Add external consultants, Scope reductions, Delay launch, Push regulator expectations proactively, Other
• Are there upcoming external events (audits, clinical milestones, supplier changes) that could materially change the submission readiness in the next 60–120 days? Please list.

What Would Reviewer-Grade Acceptance Actually Look Like?

• If a reviewer with your target regulator opened the package, what are the three things you absolutely want them to say or see immediately?
• Which reviewer objections have you seen repeatedly across prior submissions or in your market segment? Options: Insufficient testing rationale, Poor claim-definition, Risk controls not linked to verification, Inadequate biocompatibility or sterility evidence, Lack of clinical justification, Other
• Would you like us to map a reviewer-expectations checklist to your submission and surface the top 5 must-fix items before finalization? Options: Yes — map and prioritize, Yes — map only, No — not needed
• Do you have prior communications with regulators (meeting minutes, deficiency letters, Q-Sub responses) we should incorporate into the package? Options: Yes — all available, Some — partial, No previous communications
• Which acceptance criteria do you already use internally to sign off a package (e.g., traceability complete, test coverage 100%, clinical evidence threshold)? Please list or attach.

If First-Time Success Isn't Reality, What’s the Plan B?

• Be candid: do you have an internal resubmission playbook or SOP for responding to deficiency letters or NB review comments? Options: Yes — documented and rehearsed, Partial — informal steps, No — rely on ad hoc response
• If the regulator issues a major deficiency, who will lead the technical response and who approves the messaging?
• What is your acceptable tolerance for a delayed market entry (weeks/months) before leadership demands an alternative path? Options: 2–4 weeks, 1–3 months, 3–6 months, >6 months / business critical
• Which contingency options are you open to if key test data are unfavorable: additional testing, design changes, labeling restriction, clinical supplement, or market segmentation? Options: Additional testing, Design modification, Label claim narrowing, Pursue another jurisdiction first, Clinical supplement, Not open to changes
• What internal escalation path exists for urgent resource needs (budget, outside labs, executive sign-off)?

Final Check — What Would Make Us All Sleep Better?

• What are the top three outcomes that would make you consider this engagement an unqualified success? Options: First-cycle clearance/approval, Clear governance and timeline adherence, No major post-market actions, Transferable documentation and templates, Improved internal capability
• Which artifacts would you want returned as company-owned deliverables (editable DHF, trace matrix, test protocols, redline-ready submission)? Options: Editable DHF, Traceability matrix, Raw test data and reports, Submission-ready PDFs, Templates and SOPs, Other
• How would you prefer we surface risks and progress during execution—weekly dashboard, twice-weekly calls, email summaries, or an on-platform shared workspace? Options: Weekly dashboard, Twice-weekly calls, Email summaries, Shared platform workspace, Combination
• If we begin with a focused pre-deployment gap assessment, are you prepared to grant access to one core artifact (choose one) for our reviewers to evaluate within 48–72 hours? Options: Design History File (DHF), Risk Management File (RMF), Key test report bundle, Clinical evaluation report, Labeling/IFU
• Finally, what is the best way and time to schedule an initial 60–90 minute discovery workshop with your cross-functional team? Options: This week — morning, This week — afternoon, Next week — morning, Next week — afternoon, Later — propose dates

Tell Me About Today (A Quick Picture)

• Which single submission or regulatory objective are we focusing on right now? Options: US 510(k), US PMA, EU MDR re-certification, EU CE Technical File (new device), EU Technical Documentation (legacy transition), Other / Multi-jurisdiction
• Briefly describe the product and its intended use in one or two sentences (this helps us match reviewer experience).
• What is the current target filing date or regulatory milestone you're committed to? Options: Within 30 days, 30–60 days, 2–3 months, 3–6 months, 6+ months, No firm date
• Who on your team is the day-to-day owner for this submission? Options: VP Regulatory, Director QA/RA, Regulatory Manager, Consultant/Contractor, CEO/Founder, Other
• What triggered this engagement—new product launch, audit/deficiency, legacy recertification, competitor pressure, or something else? Options: New product at submission-ready, Responding to an agency deficiency, EU MDR recertification deadline, Investor / commercial timeline, Post-market surveillance issue, Other

If This Goes Sideways, What Actually Breaks?

• Imagine the submission is rejected or delayed—what is the single biggest consequence for your organization? Options: Launch delayed (months), Lost revenue / missed contract, Clinical trial delay, Market withdrawal, Regulatory enforcement/inspection, Reputational damage, Other
• How often have similar submissions hit major issues in the past 24 months? Options: Never, Rarely (1–2 times), Occasionally (3–4 times), Frequently (5+), Not sure
• Tell me about a past rejection or deficiency that mattered—what was the root cause and how long did remediation take?
• Which of these impacts would you rank as most urgent to avoid? (pick up to two) Options: Time-to-market delay, Loss of notified body certification, Increased cost to remediate, Loss of key customers, Regulatory fines / enforcement, Clinical hold
• How does your leadership team quantify acceptable delay or risk—do you have a hard deadline tied to revenue, commercial agreements, or funding? Options: Hard deadline (non-negotiable), Target with some flexibility, No formal deadline, Depends on commercial milestones, Unsure

Who Really Decides (And Who Just Thinks They Do)?

• Who are the decision makers who must sign off before a filing goes out—and who tends to slow decisions down? Options: VP Regulatory, CEO/Board, Quality Director, Head of Clinical, Head of Engineering, Commercial Lead, External Legal/Consultant
• How confident are you that each stakeholder understands the tradeoffs between speed, evidence, and risk? Options: Very confident, Somewhat confident, Not confident, Not sure
• Describe a recent meeting where a regulatory decision was delayed—what information was missing and who pushed back?
• Do you have existing relationships or named contacts at the agency or notified body that can clarify expectations? If yes, who? Options: Yes—named contacts, Yes—informal contacts, No established contacts, We prefer not to contact agencies directly
• Which governance rhythm best reflects how you make submission decisions today? Options: Weekly RA review, Biweekly leadership review, Ad-hoc as issues arise, Monthly steering committee, Other

Where the Paperwork Breaks (and Why)

• If a senior reviewer opened your submission folder today, what three documents would give them the clearest picture—and are they final and available? Options: Device description & intended use, Risk management file (ISO 14971), Verification & validation reports, Clinical evaluation report / literature, Labeling and IFU, Traceability matrix (reqs->tests)
• Which of the following critical artifacts are incomplete, out-of-date, or missing? Options: Design history file, Biocompatibility testing, Electrical safety/EMC reports, Software validation, Clinical evidence, Usability/IFU testing, None—all present
• Walk me through the single biggest documentation gap you suspect exists and why it's been hard to close.
• How consistent are your templates and reviewer-facing narratives (e.g., summary of testing, rationale for predicate/clinical strategy)? Options: Highly consistent, Somewhat consistent, Inconsistent, No formal templates
• Who owns the handoff between engineering, clinical, and regulatory documentation, and has that handoff failed before? Options: Regulatory owner, Quality owner, Product/Engineering owner, Cross-functional team, No clear owner

What Would a Reviewer Praise—and What Would They Flag?

• If you were inside the review office, what assumption about your submission would surprise you the most? Options: We lack sufficient clinical context, Our test matrix is incomplete, Traceability is weak, Labeling is inconsistent, Risk controls unclear, Other
• Which reviewer comments have you seen repeatedly (from agency or notified body feedback) over the past two years? Options: Insufficient risk analysis, Missing test methods/acceptance criteria, Inadequate clinical rationale, Poor labeling/IFU, Incomplete traceability, Other
• How often do you run internal 'reviewer eye' checks (i.e., ex-FDA reviewer walkthroughs) before filing? Options: Always, Often, Sometimes, Rarely, Never
• Describe one reviewer expectation you think you meet exceptionally well, and one you worry you don’t.
• Would you be open to a focused pre-submission review from an ex-reviewer to identify fatal flaws before filing? Options: Yes—immediately, Yes—but later in the timeline, Maybe after a gap assessment, No

What Does 'Success' Actually Feel Like for You?

• Beyond clearance or CE marking, what three business outcomes matter most for this submission? Options: Faster market launch, Maintain existing market access, Lower post-market surveillance burden, Investor milestones, Commercial contracts, Reduced internal burn
• Which of these timelines would you describe as a true 'success' versus merely 'acceptable'? Options: On or before target date, Within 30 days after target, Within 90 days, No fixed expectation—quality over speed
• How will you know we’ve done our job—what are the acceptance criteria from your leadership and from the reviewers?
• What tradeoffs are you willing to accept to shorten the timeline—more testing, additional consultants, or higher commercial risk? Options: More testing / stronger evidence, Bring in external consultants, Prioritize certain markets first, Accept conditional approval pathways, Not willing to trade off
• What would immediate peace of mind look like after our first 30 days working together?

What's the Smallest Change That Would Save Months?

• If one focused intervention could remove the biggest bottleneck, which would you pick: a documentation overhaul, targeted testing, a reviewer-led gap assessment, or stakeholder alignment? Options: Documentation overhaul, Targeted testing, Reviewer-led gap assessment, Stakeholder decision alignment, Commercial/legal negotiation
• What internal resources (people, test labs, budget) can you make available in the next 30 days to accelerate progress? Options: Dedicated RA lead time, Engineering support, Test lab budget, Clinical resources, External consultant hours, Limited availability
• What timeline does your leadership expect for a decision to engage outside help (i.e., commit budget and terms)? Options: Immediately, Within 2 weeks, Within 1 month, Within 3 months, Undecided
• Are there contractual or procurement steps (legal reviews, PO approvals) that typically add weeks to starting an engagement? Options: Yes—multiple approvals, Yes—single legal review, No formal procurement, Unsure
• What would make you say 'yes' to a mutual commit today—fixed timeline certainty, a defined scope of deliverables, risk-sharing on outcomes, or something else? Options: Fixed timeline guarantee, Clearly defined deliverables & acceptance criteria, Pricing tied to milestones, Trial engagement / phased approach, Other