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Regulatory & Quality

Market access and a quality system that holds up in the audit.

Registration, quality systems, risk management and audits planned together, so the work done for one market becomes the basis for the next.

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🏆Top Medical Device Regulatory Consultant · LatAm 2025
✓ISO 9001 certified in Brazil
🌐Service in PT · EN · DE

Is this for you?

Who we do this for

First registrationYou need classification, a strategy and a quality system the authority will accept.

A system to build or updateYour system does not yet cover ISO 13485, MDSAP, ANVISA GMP or the FDA QMSR.

Audit or inspection aheadYou want to test the system before the certifier or inspector does.

Suppliers to qualifyYou need to audit suppliers in Brazil or abroad.

In numbers

Where quality is checked

31,215ISO 13485 certificates worldwideacross 43,957 certified sites. It is the most common basis for showing a medical device quality system.

31,426MDSAP audits conductedfrom 2018 to May 2025, in 82 countries. One audit is used by the five authorities in the program, including ANVISA, the FDA and Health Canada.

#1CAPA is the FDA’s most cited item279 of 2,660 observations in device inspections in fiscal year 2025. Complaint handling (211) comes next.

Sources: ISO Survey 2024 (ISO); MDSAP Today, IMDRF, 2026; FDA, Inspection Observations, fiscal year 2025.

What do you need?

Pick a topic and see what it usually involves

Registration and market access

Classification, market strategy and a dossier in each authority’s format. To see your product’s path, market by market, use the Sobel Route tool.

Usually includes

Classification and regulatory route
A market sequence that builds on what you have
Technical dossier in each authority’s format
Follow-up of authority requests

References

RDC 751/2022EU MDRFDAHealth Canada

Find your regulatory path →

Tap a topic to see the details.

In each market

The quality reference each authority usually uses

A well-built base usually serves several markets. What changes is how you show it.

Brazil · ANVISA

Medical devices

ANVISA applies its own Good Manufacturing Practices (RDC 665/2022). For class III and IV devices, registration usually requires the ANVISA GMP certificate (CBPF), and MDSAP reports can support that process.

Cosmetics

Good Manufacturing Practices for cosmetics (RDC 48/2013).

The exact requirement depends on the product, the class and the route. We confirm it in your assessment.

How we work

From assessment to audit, in five steps

You follow every step in the Sobel Client Workspace.

1AssessmentWe look at the product, the markets and the system you already have.Sobel
2Prioritised planWhat to do first, for which market and with what effort.Sobel
3Implementation with your teamDocuments, processes and training, at your company’s pace.Sobel and you
4Internal or mock auditWe test the system before the certifier or inspector does.Sobel
5Certification and upkeepSupport during the audit or inspection and with the actions that follow.Sobel and you

Talk to a specialist

Together from day one

Regulatory strategy and safety evidence in one plan

Many delays start when regulatory strategy and safety evidence are planned apart. At Sobel, both teams work on the same dossier.

Clinical Evidence & Product SafetyBiological evaluation, toxicology and clinical evaluation.→Sobel RouteSee what we do in each market and build your path.→Product stuck at ANVISA?Rejected, under requirement or stalled.→

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 Clinical Evidence & Product Safety team.

Regulatory, five markets

ANVISA, FDA, EU MDR, 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 (now Dentsply Sirona)

Questions, answered

Frequently asked questions

Rules cited on this page: ISO 13485:2016 · ISO 14971:2019 · ISO 19011 · ISO 22716 · RDC 665/2022 · RDC 48/2013 · RDC 751/2022 · FDA QMSR · MDSAP

Does Sobel issue ISO 13485 or MDSAP certificates?

No. Certification is done by accredited certification bodies or, for MDSAP, by auditing organizations recognised by the authorities. Sobel prepares the system, the documentation and the team for that audit.

Can one quality system serve several markets?

In general, yes. An ISO 13485 base is usually the starting point, and each authority’s own requirements are added to it. What each market asks in your case, we confirm in your assessment.

Do you audit suppliers outside Brazil?

Yes. Audits can be on site, remote or hybrid, depending on the supplier and the risk involved.

Do you work with cosmetics manufacturers?

Yes. For cosmetics, we work with Good Manufacturing Practice and ISO 22716, as well as supplier audits.

Which languages do you work in?

Portuguese, English and German.

Market access and a quality system that holds up in the audit.

Who we do this for

Where quality is checked