Quality Management Systems & Compliance
Clarify the quality-system exposure before audit findings, remediation pressure, or growth puts product continuity at risk.
A quality issue rarely stays inside the quality function. Weak controls can affect regulatory confidence, clinical evidence, post-market response, operational execution, and the organization’s ability to keep products in market.
SHOTUNE provides founder-led quality and compliance advisory for medical device companies operating under FDA, EU MDR, audit, inspection, Notified Body review, remediation, and continued-compliance pressure. The work helps leadership determine where control is weakening, which risks are material, and what must be addressed first.
Request an EU MDR Readiness Review
A private first conversation to understand the quality-system pressure, locate the connected exposure, and determine whether SHOTUNE is the right fit.
The decision context
Quality-system weakness can become a product, regulatory, and continued-compliance problem.
Weak controls can affect regulator confidence, product availability, post-market response, inspection readiness, remediation, and technical-documentation integrity. Leadership needs to distinguish an isolated correction from a wider control failure before additional work proceeds.
Audit and inspection readiness
Determine whether the controls operate consistently and whether the organization can demonstrate that control when an auditor or inspector examines the system.
Regulatory confidence
Keep quality-system outputs aligned with the regulatory, clinical, risk, and post-market positions the organization must defend.
Post-market control
Connect complaints, vigilance, surveillance, CAPA, risk management, and escalation so meaningful signals are recognized and acted on.
Product continuity and compliance
Make unresolved risks, control evidence, and governance responsibilities visible before they affect renewal, remediation, Notified Body review, or continued market access.
When to escalate
Escalate when recurring quality signals begin changing the regulatory or compliance decision.
Senior quality judgment becomes especially important when findings repeat, functions are no longer aligned, remediation activity is expanding, or the organization cannot explain with confidence how the system is controlling the exposure.
- Audits are being passed, but leadership cannot demonstrate that the system remains consistently in control.
- CAPA, design control, risk management, complaints, clinical evidence, and post-market processes are producing conflicting signals.
- Recurring findings or product issues are beginning to affect regulatory posture, product continuity, or control confidence.
- The organisation is scaling, remediating, entering new markets, preparing for renewal, or approaching Notified Body scrutiny.
- Remediation work is growing without clear priorities, decision ownership, or evidence that the underlying system is improving.
Strategic scope
Where SHOTUNE helps leadership bring the control system back into view.
The work connects governance, CAPA, design control, risk management, inspection readiness, remediation, post-market activity, and cross-functional ownership under FDA and EU MDR expectations.
QMS and governance risk review
Evaluate whether the governance model, management oversight, system outputs, escalation paths, and decision ownership give leadership a reliable view of control.
CAPA, design control, and risk integration
Examine whether corrective action, design control, risk management, complaints, clinical evidence, and post-market processes reinforce one another or operate as disconnected systems.
Inspection, audit, and Notified Body readiness
Identify the control gaps, unresolved evidence, recurring signals, and ownership issues most likely to surface during FDA inspection, Notified Body audit, renewal, or technical-documentation review.
Remediation and system strengthening
Prioritize corrective action, clarify leadership ownership, and strengthen the underlying control system instead of treating remediation as a document-production exercise.
The integrated control position
Quality governance works only when regulatory, clinical, risk, and post-market signals support the same position.
A quality system can appear complete while the organization still acts on conflicting evidence, risk conclusions, escalation priorities, and interpretations of control. SHOTUNE helps leadership identify where the operating story no longer agrees and which weakness must be addressed first.
Regulatory strategy
Quality-system outputs support the regulatory positions, product changes, commitments, and market-access decisions the organization must defend.
Clinical evidence
Clinical evidence, intended claims, benefit-risk conclusions, and lifecycle obligations connect to the controls responsible for sustaining them.
Risk management
Risk conclusions actively inform design decisions, CAPA, complaints, post-market activity, change control, and escalation.
Post-market systems
Complaints, vigilance, surveillance, CAPA, and remediation are evaluated as connected signals rather than separate queues of work.
Control credibility
The organisation can explain how control is maintained as products, markets, design changes, post-market obligations, renewals, and regulator scrutiny increase.
How SHOTUNE works
Founder-led advisory focused on whether the system is truly in control.
SHOTUNE begins with the quality-system pressure leadership is trying to understand. Dr. Shola Sulaimon reviews the governance model, control evidence, recurring signals, risk conclusions, and ownership behind the issue.
The work then turns that assessment into a clearer view of the material exposure, the priorities requiring attention, and the decisions the organisation must carry into remediation, inspection readiness, renewal, or continued compliance.
Define the control question
Clarify the finding, recurring signal, remediation issue, inspection concern, or governance decision leadership must be able to address.
Test the operating evidence
Examine whether CAPA, design control, risk management, complaints, post-market processes, management oversight, and escalation support the stated quality position.
Map the connected exposure
Distinguish isolated correction from structural weakness affecting regulator confidence, patient safety, product continuity, market access, or continued compliance.
Set priorities and ownership
Translate the assessment into the next decisions, responsible owners, evidence requirements, and sequence of corrective or governance work.
Founder accountability
Senior quality judgment remains close to the work from the first signal through the next control decision.
Every quality and compliance engagement is led directly by Dr. Shola Sulaimon. She works with leadership and technical teams to evaluate the operating evidence, challenge assumptions, connect quality signals to their wider regulatory, clinical, risk, post-market, and technical-documentation consequences, and clarify which weaknesses require action first.
The objective is a stronger control position that leadership understands, technical teams can execute, and the organisation can demonstrate through audit, inspection, remediation, renewal, Notified Body review, and ongoing operation.
Frequently asked questions
Questions leadership often brings into the first conversation.
Our quality system passes audits, but regulators still raise concerns. Can SHOTUNE help?
Yes. Passing an audit does not always prove that the system remains consistently in control.
SHOTUNE can examine the concerns being raised, the evidence produced by the QMS, recurring signals, and whether quality, regulatory, clinical, risk, and post-market outputs support the same position.
How does SHOTUNE strengthen quality systems for scaling and global expansion?
SHOTUNE helps leadership evaluate whether the current governance model, controls, resources, decision ownership, and escalation paths can support product growth, design change, market expansion, renewal, and increasing post-market obligations.
The scope is based on the organization’s actual pressure, regulatory commitments, product portfolio, and current system maturity.
Can SHOTUNE help us prepare for FDA inspections, Notified Body audits, or renewal review?
Yes. SHOTUNE can review control evidence, recurring weaknesses, management oversight, ownership, and response posture before an FDA inspection, Notified Body audit, renewal, or technical-documentation review.
The purpose is to identify material gaps early enough for leadership and technical teams to respond deliberately rather than react once scrutiny begins.
How is risk management integrated with clinical evidence and regulatory strategy?
Risk management should inform design, intended claims, clinical evidence, CAPA, complaints, PMS, PMCF, change control, and regulatory decisions.
SHOTUNE helps identify where those connections are weak or where the documented risk position no longer matches clinical, post-market, or operating evidence.
Can SHOTUNE help when CAPAs, audit findings, or post-market issues keep recurring?
Yes. Recurring CAPAs, findings, complaints, or post-market issues may indicate that root causes, ownership, risk relationships, or system controls have not been resolved.
SHOTUNE helps leadership examine the pattern, determine whether the weakness is isolated or structural, and decide where corrective effort should be concentrated.
How is SHOTUNE different from traditional quality consultants?
SHOTUNE is founder-led, cross-functional, and decision-focused. The work is intended for situations where leadership needs senior quality judgment close to the regulatory, clinical, operational, risk, post-market, and technical-documentation consequences.
It is not built around producing SOP volume or maintaining documents without first determining whether the underlying system is operating effectively.
What outcome should leadership expect from an initial quality engagement?
The organization should leave with a clearer understanding of the control question, which weaknesses are material, how those weaknesses affect regulatory confidence or product continuity, and which corrective, governance, or evidence decisions should happen next.
The next step
Need a clearer view of the quality-system exposure before the next audit, remediation, renewal, or Notified Body review?
Bring the audit finding, inspection concern, recurring issue, remediation effort, or governance question. 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 control question, the exposure, and the next responsible step.