Guiding You Through Complex Medical Decisions
Our Mission
To help medical device innovators bring safe, effective, and breakthrough technologies to market faster by transforming regulatory complexity into a strategic advantage.
We deliver this through:
- Strategic FDA and global regulatory pathway optimization
- Robust clinical evidence generation and lifecycle clinical strategy (CER, CEP, PMCF)
- ISO 13485/ISO 14971 quality and risk management excellence
- Global regulatory intelligence enabling scalable, multi-market expansion
What Sets Us Apart
Comprehensive Expertise
With a background that spans clinical research, regulatory affairs, and product development, Dr. Sulaimon brings deep lifecycle experience from concept through post-market surveillance. She has successfully guided more than 70 CE Mark approvals and multiple FDA submissions across Class I–III medical devices.
Global Regulatory Insight
We understand the nuances of FDA, and frameworks—because we’ve led them. Having developed and executed regulatory strategies for global portfolios, we help companies anticipate requirements and avoid costly delays.
Evidence-Based Strategy
Our consulting is rooted in scientific rigor and data-driven decision-making. Whether designing clinical evaluations, managing CERs and PMCF Plans, or preparing submissions, we ensure every recommendation is backed by robust evidence and compliance excellence.
Client-Centric Collaboration
We operate as a true extension of your team—offering transparent communication, actionable insight, and strategies tailored to your product’s unique pathway. Every engagement is designed to accelerate success while maintaining compliance integrity.
Dedicated to Your Medical Device Commercialization.
How We Help
- Regulatory Strategy & Compliance – Comprehensive support for FDA and global submissions, audits, and remediation.
- Clinical Research & Operations – Trial design, oversight, evidence generation, and CRO/vendor management.
- Medical Writing & Documentation – Development of submission-ready CERs, CEPs, SSCPs, and clinical documentation.
- Market Access & Strategic Advisory – Commercialization and go-to-market planning to bridge regulatory and business goals.
Guiding You Through Every Step of Your Medical Device Commercialization.”
Shola Sulaimon, DVM, MSc, PhD.
Founder & Principal Consultant
Dr. Shola Sulaimon is a global regulatory and clinical strategy leader helping medical device innovators turn regulatory complexity into competitive advantage. With over 18 years of MedTech leadership and a proven record of 70+ successful EU technical document submissions leading to CE Mark approvals, she partners with organizations to accelerate market entry while maintaining uncompromising global compliance across FDA, EU MDR, and IVDR frameworks.
As Founder & CEO of SHOTUNE Medical Consulting Group and a former senior leader at Medtronic, Dr. Sulaimon brings deep expertise across regulatory strategy, clinical evidence, portfolio execution, and post-market excellence—delivering the infrastructure required for sustainable commercial success.
Her multidisciplinary foundation—combining a PhD in Clinical Sciences, Veterinary Medicine training, and PMP certification uniquely equips her to solve complex, cross-functional regulatory challenges that demand both scientific precision and strategic foresight.
Shola’s expertise spans strategic planning, global submissions, clinical evaluation, risk management, and team leadership enabling medical device companies to reduce time to market while building stakeholder trust and managing post market surveillance with excellence.
Education & Credentials
PMP Certified – University of California, Berkeley
Strategic AI Certificate Program at the University of San Francisco