Start with the decision that needs senior review.
Regulatory pressure rarely stays inside one function. An EU MDR renewal, Notified Body finding, evidence gap, quality weakness, or technical-documentation inconsistency can quickly affect certificate timing, product continuity, resource allocation, and revenue.
SHOTUNE provides defined, founder-led assessments that connect the relevant documentation, identify material exposure, and give leadership a prioritized decision path.
Start with the engagement that matches the decision in front of leadership.
Each engagement has a defined scope, named deliverables, a stated process, clear exclusions, and one next step. If the situation does not fit one of these scopes, SHOTUNE can still determine the appropriate advisory path.
EUDAMED registration exposure · 28 November 2026
EUDAMED Exposure Map
4–6 weeks, depending on portfolio scope
Which devices carry an incomplete or non-compliant EUDAMED registration position, the compliance date that applies to each, and the revenue exposed behind it.
Start here if: Leadership cannot confidently state which EU devices are correctly registered, which records are exposed, and what revenue sits behind the gap.
A device-level view of registration readiness, finding classification, data gaps, commercial exposure, and the critical path to the applicable deadline.
- Existing devices must be reconciled against the applicable registration position
- Data readiness and registration ownership are unclear across the portfolio
- Leadership needs the exposure quantified by device or product line
A device-level exposure register, finding classification, data-gap list, revenue-exposure view, dated critical path, and executive readout.
EU MDR renewal, submission, or Notified Body pressure
EU MDR Renewal & Notified Body Readiness Review
1–4 weeks
Whether the technical documentation is positioned to withstand Notified Body review, and where unresolved deficiencies may threaten the submission path or certificate timeline.
Start here if: A submission, renewal, or Notified Body review is approaching and leadership needs to know whether the package and timeline will hold.
A bounded readiness review that tests the package, predicts likely deficiency pressure, models the timeline, and separates pre-submission remediation from work that can wait.
- An EU MDR renewal, surveillance review, or submission is approaching
- The file was built under MDD and has not been independently tested against MDR expectations
- Prior findings or evidence gaps may create another deficiency round
A readiness report, deficiency-risk register, submission-timeline model, prioritized remediation sequence, and executive readout.
Portfolio exposure, deferred decisions, or unclear ownership
Portfolio Cliff™ Diagnostic Assessment
1–3 weeks
Where the portfolio is exposed across eight decision zones, which risks are connected, and which decisions are being deferred or left without clear ownership.
Start here if: Leadership does not have one defensible picture of portfolio exposure, connected risks, deferred decisions, and accountable owners.
An executive assessment that connects leadership, portfolio, evidence, data, renewal, resource, commercial, and acquisition exposure into a named decision set.
- Leadership does not have one defensible view of portfolio exposure
- Important decisions are crossing functions without a named owner
- Regulatory, clinical, commercial, and governance signals are telling different stories
An eight-zone assessment, Detection Matrix, Decision Debt Index™, decision register with owners and deadlines, and executive readout.
Clinical evidence, equivalence, or PMCF exposure
Clinical Evidence & PMCF Strategy Review
1–3 weeks
Whether the clinical evidence supports the claims being made for it, where the evidence position is exposed, and what remains feasible before the certificate deadline.
Start here if: The organization cannot confidently determine whether the current evidence supports its claims or whether remaining evidence options can close in time.
A structured evidence review covering claim support, equivalence, literature-search reproducibility, PMCF usefulness, and the practical feasibility of the remaining evidence pathways.
- The evidence position relies heavily on equivalence
- PMCF activity is not producing usable evidence for the next evaluation
- Leadership needs to know which evidence options can still close in time
A claim-to-evidence map, equivalence-position assessment, evidence-gap register, feasibility model, and executive readout.
What leadership receives
Every engagement converts technical findings into a defined executive decision package.
Written findings
Material findings supported by the documents and information reviewed.
Prioritized exposure
Gaps ranked by significance, timing, and potential business consequence.
Decision ownership
Required decisions assigned to the appropriate owners and deadlines.
Executive readout
A focused discussion of what is exposed, what must happen next, and which options remain available.
Independent assessment before implementation
SHOTUNE’s defined engagements begin with assessment and decision support. Each engagement has a defined scope, named deliverables, an agreed timeline, written assumptions, and a fixed fee confirmed through a statement of work.
Implementation, remediation, technical-documentation authoring, or embedded support is not automatically included. When execution support is required, it is discussed, scoped, and priced separately after the assessment findings have been delivered.
How to engage SHOTUNE
Clarify the situation
Discuss the portfolio, deadline, known concerns, and leadership decision.
Confirm the engagement
Receive a written proposal defining the scope, deliverables, timing, assumptions, exclusions, and fixed fee.
Receive the decision package
Receive the written findings, priorities, decision owners, deadlines, and executive readout.
Start with the decision in front of leadership.
Bring the deadline, portfolio, known finding, or decision that needs greater clarity. The first conversation will determine the immediate pressure, the connected exposure, and which engagement—or alternative path—is most appropriate.