About SHOTUNE
Founder-led judgment for EU MDR readiness and complex medical device decisions.
Dr. Shola Sulaimon helps medical device leaders connect regulatory, clinical, quality, post-market, risk, and technical-documentation signals before inconsistencies become formal findings or repeated review cycles.
The work gives leadership a clearer view of whether the documents support one defensible position, where material gaps remain, and what should be addressed first.
Request a Confidential Strategy Discussion
A focused first conversation to understand the situation, locate the connected exposure, and determine whether SHOTUNE is the right fit.
Founder and Principal Consultant
Dr. Shola Sulaimon
DVM, MSc, PhD, PMP
Founder-led means the senior judgment remains close to the decision from the first assessment through the path forward.
Why SHOTUNE exists
To help leadership make the connected decision before urgency removes the better options.
Medical device companies rarely struggle because one function is completely absent. The harder problem is that regulatory, clinical, quality, post-market, risk, claims, and technical-documentation conclusions are often evaluated separately.
By the time those signals are brought together, the organization may already be facing submission delay, remediation pressure, avoidable evidence work, product-continuity risk, or a decision that has become harder to resolve.
SHOTUNE brings the connected exposure into one executive view while leadership still has room to act deliberately.
Founder principle
The right time for senior judgment is before a submission, audit, diligence review, remediation effort, or commercial deadline forces the organization into a narrower set of choices.
What executive teams need
Senior judgment without fragmented accountability.
SHOTUNE is built for leadership teams that need one coherent view across approval, evidence, quality posture, product continuity, technical-documentation readiness, and execution.
Founder-led delivery
High-stakes strategy remains close to the person responsible for the judgment instead of being passed through a layered delivery chain.
Integrated perspective
Clinical, regulatory, quality, post-market, risk, claims, and technical-documentation implications are considered together instead of in isolation.
Class I to III experience
Strategy is grounded in the realities of medical device portfolios operating across different risk classes, lifecycle stages, and market pathways.
Submission realism
The technical position is considered alongside timing, document readiness, product continuity, Notified Body expectations, and internal execution.
How SHOTUNE helps
One advisory position across the documents and decisions shaping EU MDR readiness.
The work begins with the decision leadership needs to make. The appropriate advisory path is then determined by the connected exposure, not by forcing the situation into a disconnected consulting workstream.
Regulatory strategy
Pathway, classification, positioning, submission strategy, regulator response, and global market-access decisions.
Clinical evidence
Evidence strategy, intended claims, benefit-risk, PMCF, PMS, and lifecycle planning.
Quality governance
QMS strength, CAPA, design control, risk integration, inspection readiness, and remediation.
EU MDR readiness
Technical-documentation review, CER and PMCF alignment, Notified Body findings, remediation priorities, and cross-functional ownership.
How the work is carried
Direct senior involvement from the first assessment through the next decision.
SHOTUNE engagements are built around the leadership context, the exposure already present, and the decisions that must be clarified before technical and organizational work moves forward.
Step 1
Understand the decision
Clarify the regulatory, clinical, quality, portfolio, leadership, or business decision under pressure and what leadership needs to protect.
Step 2
Locate the connected exposure
Identify where pathway, evidence, claims, quality systems, risk, ownership, timing, or execution no longer support the same position.
Step 3
Set the path forward
Translate the assessment into clearer priorities, responsible owners, available options, and decisions the organization can carry forward.
Experience behind the judgment
Cross-functional experience matters when the decision does not belong to one department.
Dr. Shola’s experience spans medical, clinical, regulatory, quality, project, portfolio, and executive leadership responsibilities.
That range allows her to examine how one technical decision may affect evidence, quality controls, regulator confidence, execution, product continuity, timing, and submission readiness.
Selected experience
- Former senior leader at Medtronic
- 18+ years in MedTech
- 70+ successful CE Mark approvals
- 100+ MDD and MDR submissions
- Class I to III device portfolios
Education and credentials
- Doctor of Veterinary Medicine, DVM
- MSc, Clinical Sciences
- PhD, Clinical Sciences
- Project Management Professional, PMP
The next step
Need senior judgment before the decision becomes harder to reverse?
Bring the regulatory, clinical, quality, portfolio, leadership, or execution issue. The first conversation is used to understand the context, locate the connected exposure, and determine whether SHOTUNE is the right fit.
Request an EU MDR Readiness Review
One focused conversation to clarify the renewal context, known gaps, available documentation, and appropriate review scope.