— Frequently Asked Questions
Answers to Your Regulatory Questions
Direct answers on FDA, EU MDR, clinical evidence, and
quality strategy — drawn from 18+ years of senior
regulatory leadership.
18+
70+
Successful CE Mark
Approvals
I–III
Device Classes
Covered
100%
Founder-Led
Engagement
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How does SHOTUNE build quality systems for scaling and global expansion?
SHOTUNE designs ISO 13485-aligned quality systems to scale with portfolio growth, design changes, and global expansion. The focus is durable compliance that avoids repeated remediation as products, markets, and regulatory obligations increase.
Do you support post-market surveillance and PMCF strategy?
Yes. SHOTUNE treats PMS and PMCF as strategic assets rather than compliance burdens. We design proportionate, regulator-aligned post-market strategies that meet MDR and FDA expectations while avoiding unnecessary operational or financial strain.
How does SHOTUNE support VC, PE, acquisition, or IPO diligence?
Regulatory, clinical, and quality risks are often hidden value drivers in diligence. SHOTUNE helps executive teams identify and remediate gaps early, strengthen approval narratives, and ensure documentation and post-market strategies withstand investor, acquirer, and regulator scrutiny—protecting valuation and deal timelines.
How is SHOTUNE different from large consulting firms or independent consultants?
SHOTUNE is founder-led and executive-accountable. Clients work directly with me—not rotating junior teams or isolated freelancers. This ensures strategic continuity, faster decisions, and accountability at the level regulators, boards, and investors expect.
Who leads regulatory, clinical, and quality strategy at SHOTUNE?
All engagements are personally led by Shola Sulaimon, bringing over 18 years of global MedTech leadership experience across regulatory strategy, clinical evidence, quality management and post-market compliance for Class I–III and high-risk medical devices.
What types of companies benefit most from working with SHOTUNE?
SHOTUNE works best with organizations developing Class II–III, implantable, or high-risk devices, where regulatory outcomes materially impact timelines, valuation, and patient access—and where failure is not an acceptable option.
We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?
SHOTUNE applies a disciplined, lifecycle-based engagement model that aligns regulatory, clinical, and quality decisions early reducing downstream risk, minimizing rework, and maintaining momentum toward approval and commercialization.
Our Notified Body is pushing back on our CER, PMCF, or technical documentation. How do you handle this?
Do you engage directly with regulators and Notified Bodies?
How does SHOTUNE approach regulatory strategy differently from traditional consulting firms?
How does SHOTUNE design clinical strategy to meet FDA and EU MDR expectations?
Can you support clinical programs that are already underway or poorly aligned?
How do you integrate clinical evidence with quality and risk management?
Our quality system passes audits, but regulators still raise concerns. Can SHOTUNE help?
We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?
SHOTUNE applies a disciplined, lifecycle-based engagement model that aligns regulatory, clinical, and quality decisions early reducing downstream risk, minimizing rework, and maintaining momentum toward approval and commercialization.
Our Notified Body is pushing back on our CER, PMCF, or technical documentation. How do you handle this?
Do you engage directly with regulators and Notified Bodies?
How does SHOTUNE approach regulatory strategy differently from traditional consulting firms?
How does SHOTUNE design clinical strategy to meet FDA and EU MDR expectations?
Can you support clinical programs that are already underway or poorly aligned?
How do you integrate clinical evidence with quality and risk management?
Our quality system passes audits, but regulators still raise concerns. Can SHOTUNE help?
We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?
SHOTUNE applies a disciplined, lifecycle-based engagement model that aligns regulatory, clinical, and quality decisions early reducing downstream risk, minimizing rework, and maintaining momentum toward approval and commercialization.
Our Notified Body is pushing back on our CER, PMCF, or technical documentation. How do you handle this?
Do you engage directly with regulators and Notified Bodies?
How does SHOTUNE approach regulatory strategy differently from traditional consulting firms?
How does SHOTUNE design clinical strategy to meet FDA and EU MDR expectations?
Can you support clinical programs that are already underway or poorly aligned?
How do you integrate clinical evidence with quality and risk management?
Our quality system passes audits, but regulators still raise concerns. Can SHOTUNE help?
We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?
SHOTUNE applies a disciplined, lifecycle-based engagement model that aligns regulatory, clinical, and quality decisions early reducing downstream risk, minimizing rework, and maintaining momentum toward approval and commercialization.
Our Notified Body is pushing back on our CER, PMCF, or technical documentation. How do you handle this?
Do you engage directly with regulators and Notified Bodies?
How does SHOTUNE approach regulatory strategy differently from traditional consulting firms?
How does SHOTUNE design clinical strategy to meet FDA and EU MDR expectations?
Can you support clinical programs that are already underway or poorly aligned?
How do you integrate clinical evidence with quality and risk management?
Our quality system passes audits, but regulators still raise concerns. Can SHOTUNE help?
We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?
SHOTUNE applies a disciplined, lifecycle-based engagement model that aligns regulatory, clinical, and quality decisions early reducing downstream risk, minimizing rework, and maintaining momentum toward approval and commercialization.