Experience translated into practical action

Senior regulatory and quality leadership—personally delivered.

Experience across regulated healthcare products, global quality systems and regulatory submissions, with every engagement led directly by Leonel Vanegas.

28+ Years of regulated healthcare experience

25+ Clients served

35+ Regulatory submissions supported

Principal-Led Every engagement led directly by Leonel Vanegas

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.

Read the founder's story →

Capabilities

Six core regulatory programs.

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.

FDA Pathway Finder

Identify the right submission pathway in under 4 minutes.

Is your device life-supporting or life-sustaining?

Yes — implanted & long-term Yes — but short-term use No

Does a legally marketed predicate device exist?

Yes — clear predicate Maybe — partial match No — novel technology

What is the level of patient risk if device fails?

High — serious injury or death Moderate — recoverable harm Low — minor or no harm

QMS Gap Assessment

Benchmark your QMS against ISO 13485 + QMSR 2026.

Do you have a documented QMS aligned to ISO 13485?

Yes — fully certified Partial — gaps remain No — starting from scratch

When was your last QMS internal audit?

Within last 6 months 1–2 years ago Never / > 2 years

How many open CAPAs do you currently have?

0–2 (well-controlled) 3–10 10+ or backlog

EU MDR Readiness Check

Audit your Technical Documentation against MDR Annex II.

Do you have a current Notified Body relationship?

Yes — active contract Selecting now No relationship yet

Is your Technical Documentation MDR Annex II-compliant?

Yes — recently audited Partially — work in progress No — still MDD-format

Is your PMS / PMCF infrastructure operational?

Yes — producing PSURs Plan exists, not executing Not started

Timeline Estimator

Project realistic submission timelines.

What is your target submission?

510(k) De Novo PMA / IDE

How complete is your design verification?

Complete — ready to file Mostly — final testing left Early — protocols in draft

Will you need clinical data?

No — non-clinical only Yes — small pivotal Yes — full IDE study

Insights

Latest from the regulatory frontier.

Blog posts coming soon — import the WXR file to populate.

All articles →

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

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 — $1,299

AI 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 — $1,690

Ready to start?

Tell us about your program — we typically respond within one business day.

Book a free 30-min consult

Where Quality Systems meet Regulatory Intelligence.

Senior regulatory and quality leadership—personally delivered.

Regulatory partners who think like operators.

Six core regulatory programs.

510(k) Clearance

EU MDR Compliance

Combination Products

Quality Management

AI/ML in MedTech

IND/NDA/BLA Submissions