Emergogroup, Inc.
Emergo by UL is a global consulting firm specializing in regulatory compliance, human factors, and market access for medical devices and in-vitro diagnostics. With a presence in over 20 offices across six continents, their mission is to help clients navigate complex regulatory landscapes, achieve market success, and ensure product safety and efficacy. They offer comprehensive services, including regulatory strategy, human factors research, software solutions, and end-to-end lifecycle management, supported by a strong commitment to quality and innovation.
Industries
Nr. of Employees
large (251-1000)
Products
Regulatory affairs management platform
Cloud platform for regulatory monitoring, registration tracking, product classification, regulatory intelligence, and automated RA/QA workflows.
Digital human factors training and tools platform
Web-based suite providing human factors training, templates, tools and document libraries to support usability engineering activities and eLearning delivery.
Regulatory intelligence and educational content
Curated newsletters, resource centers, webinars and guides that summarize regulatory updates and provide practical guidance for RA/QA and HFE teams.
HFE eLearning course catalog
Structured online course catalog covering foundational and advanced human factors topics, including certificate pathways and specialized validation training.
Regulatory affairs management platform
Cloud platform for regulatory monitoring, registration tracking, product classification, regulatory intelligence, and automated RA/QA workflows.
Digital human factors training and tools platform
Web-based suite providing human factors training, templates, tools and document libraries to support usability engineering activities and eLearning delivery.
Regulatory intelligence and educational content
Curated newsletters, resource centers, webinars and guides that summarize regulatory updates and provide practical guidance for RA/QA and HFE teams.
HFE eLearning course catalog
Structured online course catalog covering foundational and advanced human factors topics, including certificate pathways and specialized validation training.
Services
Market access and regulatory submissions
Regulatory strategy and preparation of market submissions and registrations for medical devices and IVDs across multiple jurisdictions.
Human factors research and usability engineering
User research, usability testing, human factors validation, and usability-focused design support to reduce use-related risks.
Privacy and cybersecurity consulting for medical devices
Assessment and remediation planning for patient data privacy and device cybersecurity requirements for regulated markets.
Quality management and ISO services
ISO 13485 consulting, gap analysis, implementation support, audits and eQMS assistance to prepare organizations for certification and compliance.
Risk management consulting and training
Implementation guidance and training for risk management processes aligned with ISO 14971.
Post-market surveillance and vigilance services
Design and management of post-market surveillance programs, adverse event reporting and field corrective action reporting workflows.
Market access and regulatory submissions
Regulatory strategy and preparation of market submissions and registrations for medical devices and IVDs across multiple jurisdictions.
Human factors research and usability engineering
User research, usability testing, human factors validation, and usability-focused design support to reduce use-related risks.
Privacy and cybersecurity consulting for medical devices
Assessment and remediation planning for patient data privacy and device cybersecurity requirements for regulated markets.
Quality management and ISO services
ISO 13485 consulting, gap analysis, implementation support, audits and eQMS assistance to prepare organizations for certification and compliance.
Risk management consulting and training
Implementation guidance and training for risk management processes aligned with ISO 14971.
Post-market surveillance and vigilance services
Design and management of post-market surveillance programs, adverse event reporting and field corrective action reporting workflows.
Expertise Areas
- Medical device regulatory compliance and market access
- Global device registration and submissions (US, EU, Japan, LATAM, Asia)
- Human factors engineering and usability validation
- Quality management system implementation and ISO 13485 readiness
Key Technologies
- Regulatory intelligence and monitoring software
- Registration tracking and submission management systems
- Guided submission-builder and automated document assembly
- Cloud-based eLearning and HFE training platforms