Emergo by UL
Emergo by UL offers comprehensive medical device regulatory consulting, specializing in human factors, usability testing, and market access for global compliance.
Emergo by UL provides expert regulatory consulting services for the healthcare industry, focusing on medical devices and IVDs. They offer a full spectrum of support across the product lifecycle, including Human Factors Research & Design, Usability Testing, and Market Access consulting. Their expertise helps clients navigate complex global regulations, ensuring compliance and facilitating market entry. Leveraging a deep understanding of evolving healthcare standards, Emergo by UL assists with product classification, privacy and security requirements (HIPAA, GDPR), and post-market surveillance. They also provide digital tools and resources, such as software for regulatory monitoring and access to human factors engineering tools, to streamline RA/QA activities. With a proven track record demonstrated through case studies, Emergo by UL partners with manufacturers to achieve global expansion and optimize user-centered design. Their services are tailored to address specific manufacturer needs, ensuring adherence to international regulatory requirements and promoting innovation in medical device development.
About
**Who they are**
Emergo by UL is a regulatory consulting firm specializing in medical device and IVD compliance, with a significant focus on human factors and usability engineering.
**Expertise & scope**
* Comprehensive medical device regulatory consulting
* Human Factors Research & Design (HFR&D)
* Usability testing and evaluation
* Market access and global registration consulting
* Privacy and security consulting for medical devices and IVDs, including HIPAA and GDPR compliance
* Local Authorized Representative services
* Post-market surveillance
* Development of digital tools and platforms to simplify and automate regulatory affairs/quality assurance (RA/QA) activities
* User interface design consulting to optimize user experience and reduce errors
**Reputation / proof points**
* Offers a suite of human factors design and research tools named OPUS
* Provides digital regulatory monitoring tools and access to human factors engineering tools
* Has a platform of digital products to improve, simplify, and automate RA/QA activities
Emergo by UL is a regulatory consulting firm specializing in medical device and IVD compliance, with a significant focus on human factors and usability engineering.
**Expertise & scope**
* Comprehensive medical device regulatory consulting
* Human Factors Research & Design (HFR&D)
* Usability testing and evaluation
* Market access and global registration consulting
* Privacy and security consulting for medical devices and IVDs, including HIPAA and GDPR compliance
* Local Authorized Representative services
* Post-market surveillance
* Development of digital tools and platforms to simplify and automate regulatory affairs/quality assurance (RA/QA) activities
* User interface design consulting to optimize user experience and reduce errors
**Reputation / proof points**
* Offers a suite of human factors design and research tools named OPUS
* Provides digital regulatory monitoring tools and access to human factors engineering tools
* Has a platform of digital products to improve, simplify, and automate RA/QA activities
Additional information
Emergo by UL supports manufacturers in navigating complex global regulatory landscapes. Their services extend across the entire product lifecycle, from initial design and human factors research to market access and post-market surveillance. They emphasize the development of intuitive user experiences to minimize errors and ensure compliance with standards like IEC 62366-1. Buyers can expect support in areas such as risk analysis, user research, design evaluation, and validation testing, tailored to various user types and use environments, including home and professional healthcare settings.
Key Highlights
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Specializes in human factors research and design, including user research, analysis, design, and evaluation.
Source
“Optimize human factors research and design to bring medical products to market”
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Offers comprehensive medical device regulatory consulting, covering market access, device registration, and post-market surveillance.
Source
“Medical device market access services; Regulatory affairs consulting; Device registration; In-country representation; Post-market surveillance”
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Provides privacy and security consulting for medical device and IVD companies, addressing HIPAA and GDPR.
Source
“Privacy Security Consulting for Medical Device, IVD Companies; Data privacy consulting services; HIPAA and GDPR Overview”
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Develops and offers digital tools and platforms to improve, simplify, and automate RA/QA activities.
Source
“A platform of digital products to improve, simplify and automate RA/QA activities”
Certifications & Trust Signals
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Offers a new human factors tool providing training, tools, and resources.
Source
“Emergo by UL's new human factors tool - provides training, tools, and resources.”
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Provides software tools for digital regulatory monitoring and access to human factors engineering tools.
Source
“Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking global regulatory compliance
- Companies needing specialized human factors and usability engineering support
- IVD companies requiring privacy and security consulting
How engagement typically works
- Project-based consulting
- Development of digital tools and resources
- End-to-end lifecycle support
Typical deliverables
- Human factors research reports
- Usability testing protocols and results
- Regulatory submission support
- Market access strategies
- Privacy and security compliance documentation
Good to know
- Best when requiring expertise in medical device regulations and human factors engineering.
HQ:
Charlotte, USA
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Japan, South Korea, Australia, Brazil, Mexico, Europe, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Usability Study Types Offered:
Both
Services Offered:
User interface evaluation, Validation testing, Other
User Types Supported:
Lay user, Professional healthcare, Both
Use Environments Supported:
Home healthcare, Professional healthcare, Both
Standards Supported:
IEC 62366-1, FDA Human Factors Guidance
Has Participant Recruitment:
Yes
Has Usability Lab:
Yes
Has Remote Testing:
Yes
Rush Available:
Yes
Nda Support:
Yes
Minimum Project Size:
$50k+
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Summative study, Both
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing, Other
Standards Supported
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance, ISO 14971, Other
User Types Supported
Lay user, Professional healthcare, Both
Use Environments Supported
Home healthcare, Professional healthcare, Both
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Minimum Project Size
Custom
Pricing Model
Custom
