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Expertise
We help solve regulatory and compliance problems in the healthcare industry.
Expertise Overview
Combination Products
Digital Health Products
Health and Wellness Products
In-Vitro Diagnostic Devices
Medical Devices
Retail
We have deep expertise with a range of product types, including combination and borderline products.
Services
Comprehensive service offerings at every point in the product life cycle.
Services Overview
Market Compliance Consulting
Device Registration
In-Country Representation
Regulatory Consulting
CRO Services
QMS Compliance
Post-Market Surveillance
Testing and Validation
Digital Health Consulting
Cybersecurity Risk Management and Procurement Support
FDA Cybersecurity Guidance Consulting
Human Factors Research and Design
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Our resource library is tailored to device professionals.
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Featured Resource
QMS Compliance
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White Papers
What to Expect During an FDA QSR Inspection
Are you prepared for a random FDA audit? The United States Food and Drug Administration often announces their plans to audit your company at the...
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Our global consulting team works from 20+ offices on six continents. Let us help you expand your reach.
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Market Compliance Consulting
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Our team of regulatory, usability, and cybersecurity experts specialize in medical devices and IVDs.
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Brazil
Brazil
Emergo offers regulatory, quality assurance and representation services for companies looking to sell medical devices or IVDs in Brazil.
Device Registration
Brazil INMETRO Certification Consulting for Medical Devices
Device Registration
ANVISA Medical Device Registration and Approval in Brazil
In-Country Representation
Brazil ANVISA Registration Holder service for medical device companies
Regulatory Consulting
Certificate of Free Sale (CFS) for Medical Device Exports
Regulatory Consulting
Brazil Medical Device Regulatory Strategy Report
Regulatory Consulting
Brazil ANVISA Medical Device Classification Consulting
QMS Compliance
Medical Device Single Audit Program (MDSAP) Internal and Gap Audits
QMS Compliance
On-Site Medical Device Single Audit Program (MDSAP) Training for Manufacturers
QMS Compliance
Brazil GMP (BGMP) Quality System Compliance
QMS Compliance
Medical Device Gap, Internal, Pre-Certification and Supplier QMS Audits
QMS Compliance
Short Term or Part-Time Medical Device QA/RA Outsourcing
Post-Market Surveillance
Medical Device Vigilance Reporting for ANVISA in Brazil
Testing and Validation
Material and Chemical Characterization Testing for Medical Devices
Learn how we can help you in Brazil
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