Regulatory, Clinical & Quality Leadership for Medical Device Companies
Where Approval Failure Is Not an Option
When regulatory risk threatens timelines, valuation, and market access, SHOTUNE Medical Consulting Group (hereinafter referred to as SHOTUNE) delivers founder-led, clinical, regulatory and quality strategic leadership to secure durable approvals for medical devices (Class I-III) across FDA, EU MDR and global markets. SHOTUNE is often engaged before first submissions, pivotal clinical milestones, or EU MDR transitions when early regulatory decisions quietly determine downstream success or failure.
Proven Leadership Under FDA, EU MDR & Global Regulatory Scrutiny
18+ years of global medical device regulatory, clinical, and quality leadership
Deep cardiovascular and implantable device expertise
Who We Are
A Founder-Led Medical Technology Clinical, Regulatory, & Quality Strategy Firm
Founded by Shola Sulaimon, a former global clinical and regulatory leader at Medtronic, SHOTUNE operates with a senior-led, execution-owned model not delegated consulting. Engagements are intentionally limited to ensure founder-level judgment and accountability from strategic decision through regulatory outcome.
With over 18 years of industry experience and 70+ successful CE Mark approvals (including submissions, recertifications, and remediation) across Class I–III medical devices—particularly cardiovascular and implantable technologies—SHOTUNE helps organizations reduce regulatory risk, avoid costly rework, and achieve durable approvals that withstand FDA, EU MDR, audit, and diligence scrutiny.
SHOTUNE functions as an extension of your leadership team, integrating clinical evidence, regulatory strategy, and quality management to support confident progression from development through global commercialization
Who We Work With
Partnering With Medical Device Companies Where Regulatory Outcomes Impact Valuation
SHOTUNE engages where regulatory leadership, speed, and precision are critical—and where failure is not an acceptable outcome. SHOTUNE partners with Venture Capital (VC) -backed and Private Equity (PE)-backed medical device companies, as well as acquisition- and Initial Public Offering (IPO)-ready organizations, where clinical, regulatory, and quality outcomes directly impact valuation, diligence, and market success. This includes first-in-human programs, first EU MDR transitions, and growth-stage medical device companies preparing for their first high-stakes regulatory milestone, as well as:
VC-backed and PE-backed startups advancing Class I–III and implantable technologies toward first approval
Acquisition- and IPO-ready organizations requiring defensible regulatory and clinical strategies for diligence and valuation
Growth-stage medical device companies expanding into EU MDR and global markets under heightened scrutiny
Established manufacturers managing complex portfolios, lifecycle compliance, and post-market obligations
SHOTUNE engages where regulatory leadership, speed, and precision are critical—and where failure is not an acceptable outcome.
What We Help You Achieve
Reducing Regulatory Risk. Accelerating Durable Approvals. Protecting Enterprise Value.
Regulatory outcomes are enterprise-level risks, not operational details. Delays, non-acceptances, or post-market remediation can materially impact timelines, valuation, and investor confidence.
SHOTUNE partners with executive teams to anticipate regulator expectations, reduce approval risk, and deliver defensible regulatory, clinical, and quality strategies that withstand FDA, Notified Body, audit, and diligence scrutiny—before risk becomes exposure.
Why SHOTUNE
Why Executive Teams Choose SHOTUNE
Internal teams lack senior regulatory judgment needed to navigate complex FDA and EU-MDR decisions
Large consulting firms move too slowly or dilute accountability, putting timelines at risk
Former regulators lack execution ownership, leaving strategy disconnected from delivery
SHOTUNE provides founder-led, execution-owned leadership—bridging strategy and action when approvals, valuation, and credibility are on the line.
Compared to Large Consulting Firms
- Founder-led strategy, not delegated consulting
- Tailored, decision-driven pathways—not templated approaches
- Faster decisions with direct accountability
Compared to Independent Consultants
- Enterprise-grade experience across Class I–III and high-risk devices
- Integrated regulatory, clinical, and quality leadership under one accountable leader
- Proven execution under FDA and EU MDR scrutiny
SHOTUNE delivers the precision of a boutique with the judgment, accountability, and authority of enterprise leadership.
What SHOTUNE Is Not
SHOTUNE is Not intentionally designed for organizations seeking:
Early ideation without a defined regulatory or commercial objective SHOTUNE engages once leadership is prepared to make consequential regulatory decisions, not once everything is already built.
Short-term fixes that ignore post-market consequences our focus is approval durability across audits, PMCF, and diligence not quick wins.
Delegated consulting or rotating junior teams all engagements are founder-led and senior-accountable.
Template-driven submissions or checkbox compliance we deliver regulator-aligned strategies built for defensibility not generic pathways.
Low-cost, document-only regulatory support — we provide senior regulatory leadership for clients who understand that early decisions, not documents alone, determine long-term approval success.
Founder Value Proposition
Founder-Led. Executive-Accountable. Outcome-Driven
- SHOTUNE intentionally limits active engagements to ensure founder-level leadership and accountability on every program.
- Every engagement is personally led by Shola Sulaimon, a former global clinical and regulatory leader at Medtronic, ensuring senior accountability for strategy, execution, and regulatory outcomes.
- Escalation does not require crisis. SHOTUNE is engaged when leadership recognizes that early regulatory, clinical, and quality decisions will materially shape approval durability, valuation, and execution confidence. they gain senior clinical regulatory leadership aligned to FDA and EU MDR expectations, focused on protecting timelines, valuation, and approval success.
- Clients do not receive delegated consulting—they gain senior clinical and regulatory leadership aligned to FDA and EU MDR expectations, focused on protecting timelines, valuation, and approval success.
Founder Executive Note
“I work directly with executive teams to bring clarity on risk, control over regulatory strategy, and regulator-aligned execution—so leaders can move forward with confidence when failure is not an option. My role is to ensure my clients make the right regulatory decisions early so approvals, audits, and diligence are outcomes of foresight, not recovery.”
— Shola Sulaimon, DVM, MSc, PhD
Founder & Principal Consultant
Core Services
Regulatory Strategy & Global Pathway Leadership
Clinical Evidence & Lifecycle Strategy
Clinical evidence designed for regulator acceptance and durability supporting claims, benefit-risk, and post-market expectations without unnecessary rework.
Quality & Risk
Management
Scalable quality systems and risk frameworks built to withstand audits, inspections, and diligence as products and portfolios grow.
SHOTUNE supports decision-making from development to global commercialization.
How We Work
Every engagement is founder-led and execution-owned, ensuring clear accountability, faster decision-making, and strategies that anticipate regulator and Notified Body expectations from the outset.
A four-step approach to commercial success
Discovery
Assess regulatory, clinical, and quality risk.
Strategy
Define regulator-aligned approval pathways.
Execution
Lead delivery with senior accountability
Maintain momentum and coherent regulator engagement.
Lifecycle
Sustain approvals through post-market and growth.
Support audits, inspections, and lifecycle changes.
FAQs
We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?
Yes. SHOTUNE is frequently engaged when submissions stall due to regulator questions, evidence gaps, or strategy misalignment. I identify the root cause, recalibrate regulatory and clinical strategy to regulator and Notified Body expectations, and lead remediation with the goal of restoring momentum—not simply responding to comments.
Our Notified Body is pushing back on our CER, PMCF, or technical documentation. How do you handle this?
Notified Body pushback is rarely about documents alone—it reflects concerns about clinical defensibility and benefit-risk logic. SHOTUNE realigns regulatory, clinical, and risk narratives, closes evidence gaps, and positions submissions to withstand MDR scrutiny while minimizing iterative review cycles and rework.
Do you engage directly with regulators and Notified Bodies?
Yes. SHOTUNE supports structured FDA and Notified Body interactions, including pre-submission strategy, responses to questions, audits, and inspection readiness. My role is to ensure communications reflect how regulators evaluate safety, performance, and risk—not just how requirements are interpreted on paper.
How does SHOTUNE approach regulatory strategy differently from traditional consulting firms?
Regulatory strategy is treated as an enterprise risk decision, not a documentation exercise. SHOTUNE aligns regulatory pathways early with clinical evidence, claims, and quality systems to reduce downstream remediation, approval delays, and post-market exposure.
How does SHOTUNE design clinical strategy to meet FDA and EU MDR expectations?
SHOTUNE designs clinical strategies that directly support regulatory decisions—not just data generation. We align CER, CEP, PMCF, PMS, and risk management into a cohesive evidence strategy that demonstrates safety, performance, and benefit-risk across the full device lifecycle.
Can you support clinical programs that are already underway or poorly aligned?
Yes. SHOTUNE is often engaged to reassess legacy or active clinical programs where evidence does not adequately support regulatory claims. I identify gaps, recalibrate strategy, and realign evidence generation to regulator expectations while minimizing unnecessary additional studies.
How do you integrate clinical evidence with quality and risk management?
Under FDA and EU MDR, clinical, quality, and risk management are inseparable. SHOTUNE ensures clinical evidence supports claims, aligns with ISO 14971 risk files, and is fully integrated into PMS and QMS processes—maintaining audit-defensible compliance throughout commercialization.
Our quality system passes audits, but regulators still raise concerns. Can SHOTUNE help?
Yes. Passing audits does not always equate to regulatory confidence. SHOTUNE evaluates whether quality system outputs truly support regulatory and clinical expectations, identifies systemic weaknesses, and strengthens QMS frameworks to reduce inspection findings, regulator questions, and post-market risk.
Shola Sulaimon, DVM, MSc, PhD.
Founder & Principal Consultant
Dr. Shola Sulaimon is a global clinical and regulatory strategy leader helping medical device companies turn regulatory complexity into competitive advantage.
With over 18 years of MedTech leadership and a proven record of 70+ successful EU technical documentation submissions leading to CE Mark approvals, she has guided Class I–III and high-risk device portfolios through FDA, EU MDR, and IVDR pathways supporting both initial approvals and post-market excellence. She partners with organizations to accelerate market entry while maintaining uncompromising compliance across FDA, EU MDR, and global frameworks.
As Founder & CEO of SHOTUNE Medical Consulting Group, and a former senior leader at Medtronic, Dr. Sulaimon delivers founder-led, executive-accountable regulatory, clinical, and quality strategic leadership across the full device lifecycle. Her work spans regulatory strategy, clinical evidence generation, portfolio execution, and post-market lifecycle management building the infrastructure required for durable approvals and sustainable commercialization.
Dr. Sulaimon’s multidisciplinary foundation combining a PhD in Clinical Sciences, Veterinary Medicine training, PMP certification and strategic AI certification equips her to solve complex regulatory challenges that demand both scientific rigor and strategic judgment.
Her expertise includes strategic planning, global regulatory submissions, clinical evaluation and evidence strategy, risk and quality management and executive team leadership, enabling medical device companies to reduce time to market, strengthen stakeholder confidence, and maintain post-market compliance under FDA, EU-MDR, and regulatory scrutiny.