European rigor · Brazilian expertise
Engineers and auditors on your side of the table.
Founded by a former BSI auditor, Sobel takes medical devices, IVDs and cosmetics to market in Brazil, the US, Europe, the UK and Canada.
The founders
Engineering, certification and consulting, run with clear processes and sound numbers.
Founder and CEO
Maik Endler
Mechanical engineer trained in Germany, with more than 15 years inside the medical device industry and its certification system: Sirona Dental Systems, BSI as a Notified Body auditor, then a German regulatory consultancy, where he led the Brazilian operation.
When that consultancy left Brazil in 2021, he founded Sobel to keep serving its clients.
View on LinkedIn
Co-founder and Partner
Michele Pimentel
Career in controlling and finance, later in digital marketing as an entrepreneur. Seven years in Germany gave her both sides: the Brazilian market and what international companies expect from a partner here.
At Sobel she leads management, finance and marketing.
View on LinkedIn“Engineering, certification and consulting: few professionals have seen regulation from all three sides.”
Recognized by the industry
Top Medical Device Regulatory Consultant in Latin America 2025
Healthcare Business Review LATAM put Sobel on its cover. In the interview, Maik explains how technical expertise, commercial understanding and early planning strengthen regulatory outcomes.
Read the interviewWhat we believe
Regulation is a business decision, not just paperwork.
Regulatory strategy
We look beyond documentation to find the most effective path for your product and your business.
Scientific rigor
Decisions grounded in science, data and international regulatory standards.
Global perspective
Local requirements connected with the realities of entering international markets.
Collaborative partnership
We work alongside your team, sharing responsibility for progress and results.
How we work
We don’t just follow regulations. We help you make better decisions.
Regulatory success begins with informed choices from the start, not with correcting gaps later.
Point to each step to see what happens there.
Start with a project
A defined scope: classification, a submission, a technical file or a gap analysis.
Stay with a partner
Ongoing support after approval: changes, renewals, vigilance and new markets, with one contact.
Our journey
From engineering to international regulatory insight.
- 2008
Engineering at Sirona
Process and project engineering at Sirona Dental Systems, today Dentsply Sirona, including an assignment in China.
- 2010
Production and quality
Leading manufacturing and quality operations, connecting technical choices with business performance.
- 2013
Notified Body auditor
Assessing manufacturers across several countries, including India, from the certifier’s side of the table.
- 2019
Regulatory consulting
Moving into regulatory consulting with a German consultancy that brought Maik to Brazil, where he led its Brazilian operation.
- 2021
Sobel is founded in Brazil
When that consultancy left the country, Maik founded Sobel to keep serving its clients.
- 2022
Global consultancy
Supporting manufacturers across multiple markets, each project adapted to its regulatory environment.
- 2025
Recognized by the industry
Top Medical Device Regulatory Consultant in Latin America, Healthcare Business Review LATAM.
- Today
Building the future
Medical devices, IVDs and cosmetics across five markets, through projects and ongoing support.
The people behind Sobel
Different expertise. One integrated team.
Every project brings these disciplines together around one goal: turning technical challenges into measurable progress.
Regulatory affairs
Navigating complex regulations to ensure compliance and market access.
Biological and clinical safety
Assessing biological and clinical risks to support product safety.
Human safety
Evaluating potential risks to protect human health and well-being.
Business development
Building partnerships and identifying new business opportunities.
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.
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.
