Specialist Quality Assurance and Medical Device Regulatory Consultancy
Support for medical device companies in Brazil and Europe, ensuring regulatory compliance, quality, and agility across your processes.
Compliance Support
About Us
We are specialists in quality management and regulatory affairs for the medical device sector. With international experience and a focus on Brazil and Europe, we support companies looking to:
Support for medical device registration and market access in Brazil (ANVISA).
ISO 13485 and GMP implementation, maintenance, and certification support.
Expand business between Europe and Latin America through strategic market connectivity.
Why Choose Us
Practical, results-driven approach.
We focus on practical solutions that create value for your business.
Proven experience
We work with manufacturers and distributors of all sizes.
International expertise
In-depth expertise in ANVISA RDCs and EU MDR 2017/745.
End-to-end solutions
From registration through post-market surveillance.
Our Services
For Brazilian Companies
- ANVISA notification/registration or EU MDR support
- Technical documentation preparation
- ISO 13485 and GMP implementation
- Internal and external audits
- Import and export ragulatory support
For International Companies
- Regulatory representation in Brazil
- ANVISA notification and registration for medical devices
- Technical documentation preparation
- Internal and external audits
- Post-market surveillance (technovigilance)
Cross-functional Services
International expansion
Brazil–Europe regulatory consultancy for market expansion
Comparative Gap Analysis
Assessment of differences between ANVISA, the EU MDR, and FDA requirements to inform your regulatory strategy.
Regulatory Documentation
Preparation and review of technical documentation, risk management, and required regulatory documentation.
Tailored Training
Workshops and training tailored to your team’s needs.
Our Solution Models
Structured solutions designed to address the key needs of the medical device market.
Medical Device Notification and Registration
End-to-end support for local and international companies for medical device registration and commercialisation in Brazil and Europe.
- Preliminary classification assessment
- Documentation Review
- Technical documentation support
- Submission and follow-up
- Regulatory representation
Certification and Support (ISO 13485)
Structured quality management system implementation for manufacturers and importers.
- Initial gap analysis
- Risk Management (ISO 14971)
- Documentation Support / Development
- Department-specific training
- Audit readiness support
Ongoing Support and Back Office
Monthly consultancy and back-office support for regulatory and quality maintenance, with close follow-up.
- Regulatory updates
- Certification maintenance
- Audit support
- Unlimited consultancy support
- Post-market Surveillance (technovigilance)
Markets We Serve
Brazilian manufacturers
End-to-end support for notification, registration, certification, and ongoing compliance for medical devices in the Brazilian market.
Importers and distributors
End-to-end support for notification, registration, certification, and ongoing compliance for medical devices in the Brazilian market.
International Companies
Regulatory representation and a strategic route to market in Brazil for medical devices.
HealthTech Startups
Specialist guidance for SaMD (Software as a Medical Device) and innovative technologies.
Insights
Educational content on medical device quality and regulation
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Contact Us
We are ready to support your company in navigating a complex quality and regulatory landscape.
Contact Us
Address
Belo Horizonte - MG / Brasil
Remote Support in Brazil and Internationally
contato@qualligate.com
Phone / Whatsapp
+55 (31) 99495-9088
International Presence
We support companies worldwide, with a focus on Brazil and Europe market
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