Medical Device Regulatory & Technical Consulting Grounded in Engineering
Engineering-grounded regulatory and technical support for U.S. medical-device manufacturers, importers, and distributors — with particular depth in Brazil and LATAM market access, international supplier qualification, and device documentation.
Core Services
Focused support where technical evidence, regulatory expectations, and real-world device use meet.
Brazil & LATAM Market Access
ANVISA pathway assessment, technical dossiers, INMETRO/DIMEL strategy, ANATEL coordination, Portuguese labeling, and realistic launch planning.
International Supplier Qualification
Factory assessment, technical-file reconciliation, manufacturer negotiation, corrective actions, and supplier documentation structured for regulatory use.
Labeling & IFU Review
Regulatory content, symbols, traceability, intended-use consistency, Portuguese adaptation, and clinical-workflow review.
Technical Documentation & Risk File Review
Completeness, internal consistency, traceability, ISO 14971 risk-file structure, IEC 60601 evidence, and prioritized remediation findings.
QMSR Transition & 510(k) Readiness
Structured orientation assessments, documentation inventory, readiness review, and a remediation roadmap sequenced by exposure and effort.
Need a defined starting point?
A 30-minute scoping call clarifies the device, target market, immediate constraint, and the best next step.
How We Work
1. Scoping call
A free 30-minute conversation to understand the device, target market, and immediate constraint.
2. Complexity discovery
A structured pre-assessment of intended use, technology, claims, and likely requirements defines the scope.
3. Fixed-fee engagement
Clear deliverables and a defined timeline, followed by ongoing support when documentation needs maintenance.
Engineering judgment backed by field experience
Abdon Marques Cunha
Clinical & Electrical Engineer
Founder & Principal Consultant
Abdon brings 25+ years across clinical engineering, medical-device operations, technical leadership, supplier evaluation, and regulatory compliance. His work connects regulatory evidence with how devices are actually deployed, maintained, and used.
Selected credentials
- CREA professional engineering registration — Brazil
- Technical Responsible (RT) before ANVISA — regulatory inspections and post-market vigilance
- On-site medical-device supplier qualification and factory audits — China
- FDA medical-device regulatory training — 44 hours, July 2026
- ISO 13485 Lead Assessor — in progress
- ISO 9001:2015 Lead Auditor — TÜV Rheinland
- Graduate Certificate in Clinical Engineering — UNICAMP
- Graduate Certificate in Occupational Safety Engineering — UniEVANGÉLICA
- Postgraduate lecturer in Clinical Engineering — Instituto Navigare, since 2019
FREE REGULATORY TOOLKIT
QMSR Transition Checklist
Use this practical 28-point checklist to identify what your organization can evidence today and where a structured QMSR gap assessment should begin.
- Seven key QMSR readiness areas
- References to relevant regulatory sections
- Practical guidance for organizing findings
Get the Free Checklist
Enter your details for immediate access to the three-page PDF.
Free PDF · No credit card required. Marketing updates are optional and require separate consent.
$49 · ONE-TIME
QMSR Gap Assessment Workbook
Turn checklist findings into a structured assessment record with an Excel workbook designed to organize evidence, priorities, ownership, corrective actions, and closure.
- Six organized worksheets
- Evidence and gap documentation
- Risk, ownership, action, and closure tracking
- Unlimited internal use
From orientation to documented action
Use the free checklist to identify areas that deserve attention, then use the workbook to document what was found, assign responsibility, and track remediation through closure.
$49 USD
Start with a scoping conversation
If you are planning market entry, qualifying a supplier, or strengthening device documentation, a short conversation can help define the scope, priorities, and next steps.