For MedTech & Diagnostics
Your classification decision is a business decision. Make it like one.
510(k), De Novo, or PMA – the pathway you choose determines your clinical burden, your timeline, and your valuation. RCI Global Partners architects device regulatory and clinical strategy so the choice is deliberate, defensible, and sequenced to your runway.
Who This Is For
Built for device companies at the decisions that compound
Pre-submission clarity
You’re pre-submission and unsure whether you’re a 510(k), De Novo, or PMA — or whether you need a clinical study at all.
Market Submission
You’re ready to file a 510(k), De Novo, or PMA and need the submission built right the first time.
International Expansion
You’re a device company crossing borders — entering the U.S. market, or taking a U.S. product into the EU — and need the right pathway.
Agency Feedback & Pivots
You’ve received agency feedback, pivoted your indication, or added software/AI — and your pathway needs reassessment.
IDE Study Planning
You’re planning an IDE study and need protocol strategy that serves FDA, payers, and investors at once.
Post-Approval Strategy
You’re post-clearance and preparing for reimbursement, market access, or indication expansion.
Sequence the pathway before you spend against it
Every device program runs the same gauntlet:
classification → pathway selection → evidence planning → FDA engagement → submission → clearance → adoption.
Companies fail when they execute these out of order – generating evidence before the pathway is settled, or meeting FDA before the strategy is built. We sequence it so each step de-risks the next.
what we do for device companies
Your regulatory pathway isn’t a box to check – it’s your business strategy. We work backwards from your commercial goals to pick the right pathway, not just a pathway.
- United States (FDA): Q-Sub/Pre-Submission strategy and lead negotiation with the agency; 510(k), De Novo, and PMA applications; Breakthrough Device Designation requests
- European Union: Market applications under EU MDR and IVDR; Notified Body selection, preparation, and negotiation
- Canada: Health Canada navigation and market applications
It’s not about more data – it’s the right data, at the right time, for the right audience. Clinical evidence creates believers in your device.
- Clinical protocol development and execution under Investigational Device Exemptions (IDEs)
- Post-market clinical studies supporting safety, effectiveness, and claims expansion
- EU: Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF), Post-Market Surveillance (PMS)
- Canada: Protocol development and execution under Investigational Testing Authorizations (ITAs)
Clearance doesn’t guarantee revenue – and adoption shouldn’t be a post-approval scramble. We design it into your regulatory and clinical strategy from day one.
- Reimbursement strategy — coding, coverage, and payment across Medicare, Medicaid, and commercial payers
- Hospital implementation — Value Analysis Team (VAT) planning and support to win health-system acceptance
- KOL engagement — identifying and activating the clinical champions who accelerate adoption
- Growth strategy — claims and indication expansion, new geographies, competitive positioning
Before the clinic, the evidence plan: we define what proof your pathway actually requires – and stop you from over- or under-building it.
- Proof-of-concept evidence strategy — identifying exactly what bench, animal, or simulated-use evidence your classification and claims require
- Verification & validation (V&V) planning — test plans scoped to your submission, not to a generic checklist
- Pre-clinical study coordination, QMS foundations, and bench/animal testing support
- Investor readiness — milestone roadmaps, regulatory narratives for diligence, commercial viability framing
- SBIR/STTR and NIH grant support — including FDA-aligned clinical plans within grant submissions
Frequently supported product areas
Therapeutic-area agnostic — if it’s regulated as a device or diagnostic, we’ve likely run the pathway.
1
Strategic Roadmap
Fixed-price, fixed-scope. Your sequenced plan in weeks. The default starting point.
2
Project Engagements
Milestone-based execution: submissions, study design and management, market access projects. Flat-rate packages available for common scopes (e.g., regulatory submissions, investor readiness).
3
Advisory Retainers
Ongoing fractional leadership from 15 hours/month.
“I’d choose Shaherah Yancy any day. We’ve worked with her for less than a year and went from pre-submission to IRB IDE approval on the first attempt! She made a topic that once felt so intimidating, completely manageable.”
Annika Lundstrom
CEO, ReMinded (Finland & U.S.A.)
“Shaherah Yancy ALL. THE. WAY. I met her at a conference and she knew exactly what we needed to do right away to get to market and start our pilots. We are now FDA registered and listed with our FCC certification and moving into pre-sub for our class 2 device.”
Conner Herman
CEO, Percy Sleep (U.S.A.)
“I chose RCI for our reimbursement strategy because of the unique combination of clinical research and regulatory compliance. Deep knowledge of FDA, Medicare, and Medicaid- I will definitely use RCI again.”
Grace McNamara
CEO, EXI (Dublin, Ireland)
Class I-III
Devices, Robotics & Enabling Technologies + Drug/Biologic Programs
Pressure-test your pathway in one call
Bring your device, your current status, and your assumptions to a focused 60-minute strategy session. You’ll leave knowing whether your classification logic holds, what FDA will ask in your pre-sub or market submission, and whether a study is likely — clarity before you spend against the wrong pathway.
$500 / 60 minutes
Frequently Asked Questions
Find answers to the questions we hear most often about our services and engagement process.
Do we need a clinical study for our 510(k)?
Some 510(k)s clear without clinical data – but “some” isn’t “yours.” Predicate selection, indication wording, and technological differences determine it. That’s exactly what a discovery call resolves.
Can you lead our FDA interactions?
Yes, we develop the Q-Sub and/or market submission strategy, prepare the briefing materials, and lead negotiations with the agency.
We're a software/AI product - are we even a device?
Possibly. SaMD classification is one of our most common engagements, and the answer shapes everything downstream.
What size companies do you work with?
RCI Global Partners works with startups and emerging companies. We also work with large organizations on defined programs.
We're pre-revenue – can we afford this?
Many of our clients are pre-revenue. The fixed-price Strategic Roadmap exists for exactly this stage, and our work often supports successful seed, SBIR, and Series A raises.