Clear answers when regulatory, clinical, or quality risk starts affecting the business.
These medical device FAQs answer the questions executive teams ask when approval timelines, evidence strategy, inspection readiness, or commercial confidence are under pressure.
Start with the topic closest to the decision in front of you. If the situation is more complex than a page can answer, request a confidential strategy discussion.
Review the medical device FAQs closest to your regulatory, clinical, quality, or portfolio situation.
Start with the questions that determine fit, scope, confidentiality, and the next step.
These answers cover the buying and qualification questions that should be clear before deeper technical topics.
How is SHOTUNE different from large consulting firms or independent consultants?
SHOTUNE is founder-led, selectively scoped, and directly accountable. Clients receive integrated clinical, regulatory, and quality judgment under one senior leader rather than delegated consulting or generic deliverables.
What kinds of organizations are the best fit?
SHOTUNE is best suited to medical device organizations facing a material regulatory, clinical, quality, portfolio, or commercialization decision. Fit depends less on company size than on the consequence of the decision, so startups approaching major milestones, growth-stage companies, and established manufacturers may all be appropriate when senior judgment is needed.
What happens during the first discussion?
The first discussion is used to understand the decision, deadline, known concerns, prior findings, affected portfolio, and information already available. SHOTUNE then determines whether one of the four defined engagements is the right starting point, whether another advisory structure is more appropriate, or whether no engagement is needed.
How are engagements scoped?
Defined engagements have a named scope, deliverables, process, exclusions, and next step. After the initial discussion, the scope, timing, assumptions, responsibilities, and expected deliverables are confirmed in writing before work begins.
How is an engagement priced?
Defined engagements are fixed-fee. Scope, deliverables, timing, assumptions, and fees are confirmed in writing after the initial discussion and before work begins. If intake later reveals a materially different scope, that change is raised before additional effort is incurred.
What information should we provide?
Start with the decision or deadline, the affected product or portfolio, known concerns or prior findings, and the documents already available. The first step does not require an information dump. Share enough to establish the situation, then use the appropriate engagement and confidentiality process for more sensitive material.
Does SHOTUNE engage directly with FDA or Notified Bodies?
Not as part of a defined assessment unless the scope explicitly states otherwise. SHOTUNE can separately support regulator and Notified Body interactions, deficiency responses, submission execution, and embedded regulatory leadership under a distinct engagement structure.
What happens if the assessment identifies implementation work?
The defined assessment stands on its own. If the findings show that implementation, remediation, regulator-facing execution, embedded support, or another workstream is needed, that need is identified separately and scoped only where appropriate. The assessment does not automatically expand into open-ended implementation.
How is confidential information handled?
Confidential information is handled under the applicable SHOTUNE privacy, confidentiality or NDA, and engagement terms. The first discussion should include only the information needed to establish context. More sensitive material should be exchanged through the appropriate protected process once the applicable terms are in place.
What is not included in a defined assessment?
Defined assessments are the standard starting point where the situation fits one of the four scopes. Fractional, embedded, escalation, or implementation support may be scoped separately where the situation requires it.
Questions about submissions, pathways, regulator feedback, and escalation.
Use these answers when submission logic, market pathway, or regulator-facing strategy is no longer moving cleanly.
We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?
Yes. SHOTUNE is often engaged midstream when submissions stall because of evidence gaps, weak regulator-facing logic, or misalignment across clinical, regulatory, and quality functions. The work begins by identifying the root cause, clarifying the available options, and establishing the fastest defensible path forward.
Our pathway, classification, or predicate is still unclear. Can SHOTUNE help us decide?
Yes. Early ambiguity can delay development decisions, investor milestones, claims planning, evidence strategy, and portfolio sequencing. SHOTUNE helps leadership clarify the decision logic before downstream work becomes harder to unwind.
FDA or Notified Body feedback keeps escalating. How does SHOTUNE help?
Escalating feedback often signals a deeper misalignment between pathway, evidence, claims, and risk logic. SHOTUNE helps leadership reframe the strategy, strengthen the regulator-facing narrative, and reduce further review-cycle erosion.
Can SHOTUNE help if prior advice has already led to rework or lost momentum?
Yes. SHOTUNE assesses what is still usable, identifies where the strategy broke down, and helps the team move forward with clearer decisions and stronger regulator alignment.
Our Notified Body is pushing back on technical documentation. Is that only a document problem?
Usually not. Pushback often reflects concern about evidence defensibility, benefit-risk logic, claims, or strategic coherence. SHOTUNE helps realign the underlying position so the documentation carries a stronger and more defensible story.
Questions about evidence strategy, claims support, CER, PMCF, and lifecycle obligations.
Use these answers when the data, claims, and regulator expectations are no longer lining up cleanly.
How does SHOTUNE design clinical strategy to meet FDA and EU MDR expectations?
SHOTUNE designs clinical strategy around regulator decisions, not data accumulation. The evidence plan is aligned to claims, benefit-risk, product maturity, and lifecycle obligations so the organization can avoid overbuilding, underbuilding, or pursuing work that does not support the decision.
Our existing data does not clearly support our claims. Can SHOTUNE help?
Yes. SHOTUNE helps determine whether the issue is a true evidence gap, a claims problem, or a broader strategy misalignment, then identifies the most defensible path forward.
Can you support clinical programs that are already underway or poorly aligned?
Yes. SHOTUNE reassesses what the existing data can credibly support, what needs to change, and how to move forward without unnecessary additional burden.
Our Notified Body is pushing back on our CER or PMCF. How do you handle this?
Pushback usually reflects concern with the underlying evidence logic, not only the wording. SHOTUNE helps realign CER, PMCF, claims, and benefit-risk rationale so the complete position is more coherent and defensible.
Do you support PMS and PMCF strategy?
Yes. SHOTUNE helps design proportionate post-market strategies that meet expectations, preserve resources, and support lifecycle decision-making across markets.
How do you integrate clinical evidence with quality and risk management?
SHOTUNE aligns evidence, claims, risk management, and post-market processes so the organization can defend one integrated position across clinical, regulatory, and quality functions.
Questions about QMS strength, inspections, CAPA, risk management, and recurring findings.
Use these answers when the system appears compliant but leadership still sees operational or regulator-facing exposure.
Our quality system passes audits, but regulators still raise concerns. Can SHOTUNE help?
Yes. Passing audits does not always mean the system is strategically strong. SHOTUNE evaluates whether outputs across quality, regulatory, and clinical functions are truly aligned under scrutiny and identifies where governance needs to be strengthened.
How does SHOTUNE build quality systems for scaling and global expansion?
SHOTUNE helps build quality systems that can absorb product growth, design changes, market expansion, and post-market obligations without repeated remediation.
Can SHOTUNE help us prepare for FDA inspections, Notified Body audits, or diligence review?
Yes. SHOTUNE helps identify weak points before they become findings, strengthen inspection readiness, and improve the cross-functional quality posture regulators, auditors, and investors actually evaluate.
How do you integrate risk management with clinical evidence and regulatory strategy?
Risk management should actively shape claims, evidence, PMS, and submission logic. SHOTUNE helps ensure risk files function as part of a connected decision system rather than standalone documentation.
Can SHOTUNE help when CAPAs, audit findings, or post-market issues keep recurring?
Yes. Recurring issues often point to a structural control problem rather than an isolated event. SHOTUNE helps leadership identify the deeper pattern, strengthen governance, and reduce repeated remediation.
What does SHOTUNE do differently from traditional quality consultants?
SHOTUNE approaches quality as enterprise control architecture, not only SOP maintenance. The work connects quality outputs to regulatory, clinical, risk, and executive decisions.
Need clarity on whether your situation requires escalation?
Bring the situation. The first conversation is used to understand the context, identify the decisions that matter, and determine whether SHOTUNE is the right fit.
One focused conversation. Clear ownership. No competing next step.