Founder-Led EU MDR, Regulatory, Clinical & Quality Advisory
Start with the EU MDR, regulatory, clinical, or quality issue that needs senior review.
EU MDR renewal pressure, Notified Body findings, evidence gaps, quality weaknesses, and technical-documentation inconsistencies rarely stay inside one function.
SHOTUNE helps medical device leaders review the connected documentation, identify material gaps, clarify priorities, and give internal owners a defensible path forward.
Choose the Pressure Point
Where is leadership feeling the pressure first?
Start with the situation that most closely reflects what is happening now. Each advisory path examines the regulatory, clinical, quality, risk, post-market, and technical-documentation conclusions connected to it.
Pathway, submission, or regulator uncertainty
Regulatory Strategy & Global Submissions
The immediate concern may involve classification, claims, submission strategy, regulator feedback, EU MDR renewal, or a Notified Body response. The wider issue may involve evidence, risk, quality, post-market obligations, and the technical position the organisation must defend.
SHOTUNE connects pathway, classification, claims, evidence, regulator interaction, technical documentation, and change governance so leadership can address the material issue before delay, rework, or repeated review narrows the available options.
- The regulatory pathway or device classification remains uncertain
- FDA or Notified Body feedback is creating wider strategic exposure
- Claims, evidence, and submission logic no longer support the same position
Evidence, claims, or lifecycle exposure
Clinical & Evidence Generation
Clinical evidence may exist without fully supporting the intended claims, benefit-risk position, approval strategy, or obligations the organization must carry throughout the medical device lifecycle.
SHOTUNE connects evidence strategy, CER, CEP, PMCF, PMS, study design, claims, and lifecycle requirements so leadership can determine what evidence is truly needed before more work is committed to activity that does not resolve the underlying gap.
- Existing evidence does not fully support the intended claims or indication
- CER, PMCF, PMS, and risk conclusions are no longer aligned
- Study activity is increasing without improving approval confidence
Audit, inspection, remediation, or system pressure
Quality Management Systems & Compliance
A quality-system weakness rarely remains contained within the quality function. It can affect inspection readiness, product continuity, regulatory confidence, post-market response, and leadership’s ability to demonstrate control.
SHOTUNE connects QMS governance, remediation priorities, risk management, inspection posture, and operational accountability so leadership can address the system creating the exposure rather than continue managing disconnected findings one at a time.
- Audit or inspection readiness cannot be demonstrated with confidence
- Remediation activity is growing without clear executive priorities
- Quality weaknesses are beginning to affect regulatory confidence or product continuity
EU MDR renewal, remediation, or Notified Body pressure
EU MDR Renewal & Notified Body Readiness
The technical documents may exist, but inconsistencies across regulatory strategy, clinical evidence, PMCF, PMS, risk, claims, labelling, GSPR traceability, and prior findings can weaken the submission position.
SHOTUNE provides a founder-led review of submission integrity, identifies and prioritises material gaps, and hands internal owners a clear remediation roadmap before the next Notified Body review.
- An EU MDR renewal, surveillance review, or submission is approaching
- Clinical, regulatory, quality, risk, or post-market documents may not align
- Previous Notified Body findings require a coordinated response
One Connected Advisory Model
The right starting point is the decision in front of leadership, not the department name.
A regulatory problem may be driven by an evidence gap. A quality finding may threaten product continuity. An execution issue may be slowing a technically sound strategy. SHOTUNE considers the connected picture before recommending the most responsible advisory path.
The work is led directly by Dr. Shola Sulaimon and brings regulatory, clinical, quality, risk, post-market, and technical-documentation judgment into one review. The objective is not another isolated workstream. It is a clearer view of the material gaps, the available options, and what responsible owners should do next.
Request an EU MDR Readiness Review
Share the renewal or submission timeline, known concerns, prior findings, and the documents currently available. Each inquiry is reviewed directly, with a response typically provided within 1–2 business days.