The senior judgment behind high-stakes medical device decisions
Dr. Shola Sulaimon helps MedTech leaders connect regulatory strategy, clinical evidence, quality systems, and portfolio priorities before deficiencies, remediation burden, market-continuity risk, or lost enterprise value narrows the available options.
SHOTUNE brings these dependencies into one senior decision view so leadership can determine what to remediate, renew, invest in, deprioritize, or exit.
Dr. Shola SulaimonDVM, MSc, PhDFounder & CEO
Dr. Shola Sulaimon leads every engagement, from the initial assessment through the executive readout.
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, allowing her to examine how one technical decision may affect evidence, quality controls, regulator confidence, execution, product continuity, timing, and submission readiness.
How engagements are staffed
Every engagement is led directly by Dr. Shola Sulaimon. She conducts the assessment, develops the findings, and delivers the executive readout.
When specialist execution is required, such as US submission support, quality-system remediation, or technical-documentation authoring, the work is delivered through a named associate identified in the written proposal and introduced before work begins.
SHOTUNE’s independent assessment and decision architecture are not delegated. Specialist execution is separately defined, scoped, and priced so clients know who is responsible for every workstream.
Every engagement includes a documented working file, defined responsibilities, and an agreed continuity approach.
Why SHOTUNE Exists
Medical device exposure becomes harder and more expensive to resolve when regulatory, clinical, quality, risk, commercial, and portfolio decisions are evaluated separately. SHOTUNE brings those dependencies into one senior view while leadership still has meaningful options.
EU MDR Renewal & Notified Body Readiness
When renewal timing, technical-documentation readiness, clinical evidence, or prior deficiencies place the submission path under pressure, SHOTUNE provides an independent review before the package reaches the Notified Body.
The review identifies material gaps, likely challenge areas, remediation priorities, and the decisions leadership must make before additional review cycles narrow the available options.
Explore the EU MDR Renewal & Notified Body Readiness Review →
Need senior judgment before the decision becomes harder to reverse?
Bring the regulatory, clinical, quality, portfolio, or execution issue that needs greater clarity. The first conversation will determine the immediate pressure, the connected exposure, and whether SHOTUNE is the right fit to help.