MORE THAN COMPLIANCE
Regulatory strategy for medical devices cosmetics in vitro diagnostics
Decisions that strengthen your product and open markets in Brazil, the US, Europe, the UK and Canada.
Trusted by manufacturers in Brazil and abroad
Where does your product fit?
Start with your product. We’ll help define the right market and regulatory pathway.
Medical Devices
Regulatory strategy for medical devices, implants and software, from development to global market access.
Cosmetics
Safety assessment, labeling review and market compliance for cosmetic products in Brazil, the EU and the US.
In Vitro Diagnostics
Classification, performance evaluation, registration and post-market for reagents, analyzers and tests.
Global reach
Five markets, one strategy.
We plan your product for every market from the start, so evidence built once is reused across regulators. Point to a market to see what we cover there.
WORKING WITH SOBEL
Where is your product today?
Every client arrives at a different moment. We shape the work around yours.
01 · Project
Launching or entering a new market
A new product or a new country. You need the right route defined early and a team that takes it all the way to approval. How we work: Regulatory Projects, with fixed scope, price and timeline.
What we do
- Regulatory strategy and classification
- Gap analysis and technical file
- Submission: CE, FDA, ANVISA or Health Canada
02 · Partnership
Already on the market
Your registrations need care in every market you sell. You need a team that already knows your products. How we work: Ongoing Support, monthly, with regulatory and scientific lines and one contact.
What we do
- Renewals and changes
- Local representation and vigilance
- QMS upkeep and regulatory monitoring
03 · Priority
Facing a deadline
An authority or an auditor is waiting for your answer. You need a clear response strategy, now. How we work: Priority Project, from response strategy to technical answer.
What we do
- ANVISA requirements
- FDA additional information requests
- Notified Body and audit findings, CAPA
04 · On demand
Regulatory team or consultancy
Your team needs extra regulatory capacity, a market it does not cover yet, or specialist evidence. How we work: On-demand Support, regulatory and scientific capacity when you need it.
What we do
- Dossier review and regulatory capacity
- Submissions and representation in new markets
- Biological and clinical evaluation
Why Sobel
Regulation as a business decision, not a checklist.
Four disciplines work on every project, in the same team, from the first decision to post-market.
Strategy
Classification and market sequence decided first. The right class from day one avoids rework.
Science in house
Biological, clinical and toxicological evaluation by our own Human Safety team.
Regulatory, five markets
ANVISA, FDA, EU MDR and IVDR, MHRA and Health Canada, coordinated together.
Technology
A dedicated technology team builds the workflows that keep every project traceable and on time.
“We know how auditors think, because we’ve been one of them.”
Maik Endler
Founder & CEO
- Mechanical engineer, trained in Germany
- Former BSI auditor (Notified Body)
- Industry experience at Sirona and Dentsply
Audited and transparent
We hold ourselves to the standard we ask of you.
The rigor we ask of your product, we apply to our own work. And you see it at every step.
Hosted on a platform certified to ISO 27001 and SOC 2 Type II. A confidentiality agreement is part of every contract.
See how you follow your project →| STEP | OWNER | STATUS | DUE |
|---|---|---|---|
| Classification and strategy | Sobel | Done | Mar 04 |
| Gap assessment | Sobel | Done | Mar 18 |
| Technical dossier | Sobel | In progress | Apr 22 |
| IFU in Portuguese | Client | Waiting for documents | Apr 29 |
| Submission to ANVISA | Sobel | Planned | May 12 |
CLIENT VOICES
Trusted for decisions that move products forward.
“
Fast solutions, focused on your goals
“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”
Andreas Kohl
CEO · Andratec
“
Broad expertise, real collaboration
“I experienced always supportive, pro-active collaboration from Sobel Consult with high degree of competency in broad regulatory range.”
Mandy Blocher
Expert Regulatory Framework & Digital Transformation · Aesculap AG (B. Braun)
Latest insights
Insights and updates to help you navigate compliance with confidence.
Product rejected by ANVISA: what now?
A rejection is not the end of your product in Brazil. See the two paths, the 30-day appeal deadline and what to do before filing anything.
ANVISA technical requirement: how to answer without triggering a rejection
A technical requirement is a chance to complete your application, not a refusal. The 120-day deadline, why answers fail and how to structure a strong one.
Slow ANVISA review: what is normal and what signals a problem
Part of the wait is normal. How to tell queue from problem, why a missed technical requirement is the biggest risk and what to do while you wait.
FAQ
Questions we hear before every first call
Clear answers to what manufacturers ask us most, across Brazil, the US, Europe and Canada.
Ask your question →How do I follow my project?
Where are my documents stored, and who can see them?
Do we need a local representative in each market?
In Brazil, the US, the EU and the UK, yes: foreign manufacturers need a local representative, such as a Brazilian Registration Holder for ANVISA, a US Agent for the FDA or an EU Authorized Representative. We act as, or coordinate, your representation, so you can sell without opening a company in each country.
Should our distributor hold our registration?
You can, but the registration then depends on that partner. With an independent representative, the registration follows your strategy, so you can change or add distributors without starting over.
Can we reuse our CE marking or FDA clearance in other markets?
Often, yes. Many regulators follow IMDRF principles and accept MDSAP audit reports, so evidence built for one market can support the next. We map what transfers, what is missing and which market should come first.
