FDA Pathway Finder
Identify the right submission pathway in under 4 minutes.
Is your device life-supporting or life-sustaining?
Does a legally marketed predicate device exist?
What is the level of patient risk if device fails?
FDA · EU MDR · QMSR · 28+ years
Where Quality Systems meet Regulatory Intelligence.
Engineering FDA, EU MDR/IVDR & global regulatory success — from Series-A biotech to Fortune 100 device manufacturers. Operator-grade strategy, not consultant slide-ware.
Trusted by
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Years experience
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Clients served
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Submissions filed
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First-pass approval
Our practice
Regulatory partners who think like operators.
We are a boutique consulting firm built around a single operator with 28+ years of FDA, EU MDR, QMSR and Combination Product experience across cardiovascular, drug-delivery, IVD, biotech and digital health. We bring depth, not bench-strength inflation.
Every engagement is led personally by Leonel Vanegas. You will not be handed off to a junior associate.
Capabilities
Six core regulatory programs.
510(k) Clearance
Predicate strategy, eSTAR authoring, FDA correspondence — from concept to clearance.
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EU MDR Compliance
Notified Body strategy, Technical Documentation per Annex II/III, PMS/PMCF infrastructure.
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Combination Products
21 CFR Part 4 quality system design for drug-device and biologic-device products.
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Quality Management
ISO 13485:2016 + QMSR 2026 — built, gap-assessed, and audit-ready.
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AI/ML in MedTech
PCCP authoring, AI Act + ISO/IEC 42001 alignment, SaMD lifecycle strategy.
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IND/NDA/BLA Submissions
eCTD authoring, lifecycle management, FDA / EMA / global pharmaceutical strategy.
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How we work
A 5-step regulatory engagement.
Discovery
Free 30-min consult. We learn your product, your target markets, and your timeline.
1
Strategy
Written regulatory strategy memo — pathways, predicates, agency interactions, risk register.
2
Authoring
We draft your submission package (eSTAR, MDR Technical File, eCTD modules, QMS procedures).
3
Agency liaison
We lead Pre-Sub, IDE, IND, and Notified Body interactions on your behalf.
4
Lifecycle
Post-market surveillance, CAPA, change control — we stay engaged through commercialisation.
5
Interactive tools
Free assessments — answer 3 questions, get a directional plan.
QMS Gap Assessment
Benchmark your QMS against ISO 13485 + QMSR 2026.
Do you have a documented QMS aligned to ISO 13485?
When was your last QMS internal audit?
How many open CAPAs do you currently have?
QMS readiness:
Get a tailored gap analysis →EU MDR Readiness Check
Audit your Technical Documentation against MDR Annex II.
Do you have a current Notified Body relationship?
Is your Technical Documentation MDR Annex II-compliant?
Is your PMS / PMCF infrastructure operational?
EU MDR readiness:
Get an MDR remediation plan →Timeline Estimator
Project realistic submission timelines.
What is your target submission?
How complete is your design verification?
Will you need clinical data?
Estimated timeline:
Build a real project plan →
Insights
Latest from the regulatory frontier.
FDA QMSR
FDA’s LDT Final Rule: Three strategic options for clinical laboratories
Phase-in begins 6 May 2025. Whether you stay LDT, file 510(k)/De Novo, or restructure, the time for analysis is now.
StartupsThe regulatory strategy your Series A investors actually want to see
Most startup decks treat regulatory as a checkbox. Sophisticated investors want a defensible pathway, risk-tiered timeline, and a credible team. Here is a template.
LATAMANVISA + COFEPRIS in parallel: a LATAM medtech registration playbook
Brazil and Mexico together account for 65% of LATAM medtech spend. Registering them in parallel is achievable — here is how.
Bundle & save
Three curated bundles. Save up to 22%.
Each bundle pairs the courses our clients buy together most often — designed to take you from problem statement to submitted dossier.
QMSR-Ready Bundle
Hit the 2 Feb 2026 deadline with confidence.
- ✓ QMSR 2026 Transition Bootcamp (4.5 h)
- ✓ EU MDR Tech Doc Template Pack (12 docs)
$949 $1,180
Save $231 · 20% off
Get bundle — $949
Most popular
Combination Products Master Pack
Everything to land your drug-device submission first try.
- ✓ 21 CFR Part 4 (6 h · 14 modules)
- ✓ EU MDR Tech Doc Pack
- ✓ FDA Pre-Sub Template
$1,299 $1,670
Save $371 · 22% off
Get bundle — $1,299AI MedTech Founder Bundle
Author, file and defend an AI/ML SaMD in 90 days.
- ✓ AI/ML SaMD PCCP Workshop
- ✓ FDA Pre-Sub Template
- ✓ LATAM Regulatory Playbook
$1,690 $2,170
Save $480 · 22% off
Get bundle — $1,690Ready to start?
Tell us about your program — we typically respond within one business day.
Book a free 30-min consult