Quality Management Systems (QMS) & Compliance
Quality is not maintenance. It is enterprise control.
SHOTUNE provides founder-led quality governance for medical device companies that need systems capable of withstanding audit, inspection, remediation, and diligence scrutiny under FDA and EU MDR expectations.
What This Protects
Audit and inspection confidence
Regulator trust in system outputs
Post-market control and quality governance
Diligence readiness and operational credibility
Inspection failures cascade. Governance prevents enterprise-level exposure.
Escalate Quality Governance When
- The quality system passes audits, but leadership still lacks confidence
- CAPA, risk management, design control, and post-market systems are not well integrated
- Quality issues are beginning to affect regulatory posture or business credibility
- The organization is scaling, remediating, or preparing for transaction-related scrutiny
- Executive teams suspect the system will not withstand deeper regulator review
Why Companies Escalate Quality Governance
to SHOTUNE
- Quality consultants often update SOPs, but do not address enterprise governance gaps
- Internal QA teams may manage operations well, but lack executive-level oversight during periods of strain
- Large firms can be process-heavy, but accountability is often diffuse
SHOTUNE is engaged when quality posture has become a business risk, not just a compliance issue.
Strategic Scope
QMS assessment and governance risk review
CAPA, design control, and risk management integration
Inspection and audit readiness strategy
Remediation prioritization and leadership alignment
Quality system strengthening under FDA and EU MDR expectations
How We Work
SHOTUNE evaluates whether the quality system is merely operational—or whether it is strong enough to support regulatory confidence, inspection readiness, and enterprise-level decision-making.
Where weaknesses exist, we help leadership identify structural gaps, prioritize corrective action, and build stronger alignment between quality, regulatory, clinical, and business needs.
Quality is enterprise control—not maintenance.
What an Initial Quality Engagement May Include
- QMS and governance risk assessment under FDA and EU MDR expectations
- review of CAPA, design control, and risk management integration
- identification of structural weaknesses likely to surface in audit, inspection, or diligence
- executive-level prioritization of remediation and governance actions
Founder Accountability
- Every quality engagement is personally led by Shola Sulaimon. SHOTUNE provides senior, integrated judgment across quality, regulatory, and clinical implications—not isolated compliance support.
FAQs
1. Our quality system passes audits, but regulators still raise concerns. Can SHOTUNE help?
2. How does SHOTUNE build quality systems for scaling and global expansion?
3. Can SHOTUNE help us prepare for FDA inspections, Notified Body audits, or diligence review?
Yes. SHOTUNE helps organizations identify weak points before they become findings, strengthen inspection readiness, and improve the cross-functional quality posture that regulators, auditors, and investors actually evaluate.
4. How do you integrate risk management with clinical evidence and regulatory strategy?
Risk management should actively shape claims, evidence, PMS, and submission logic. SHOTUNE helps ensure risk files are not treated as standalone documentation, but as part of a connected system that supports defensible decisions across the product lifecycle.
5. Can SHOTUNE help when CAPAs, audit findings, or post-market issues keep recurring?
6. What does SHOTUNE do differently from traditional quality consultants?
SHOTUNE approaches quality as enterprise control architecture, not just SOP maintenance. That matters for startups trying to build correctly, growth-stage organizations scaling under pressure, and larger manufacturers that need senior judgment during audit strain, remediation, or diligence.
Need Greater Confidence That the System Will Hold Under Scrutiny?
Designed for organizations where audit-readiness on paper is not enough and leadership needs confidence under scrutiny.