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. They offer a comprehensive suite of services designed to support manufacturers throughout the product lifecycle.
**Expertise & scope**
* **Human Factors Engineering & Usability:** Expertise in human factors research, design, evaluation, and testing to optimize user experience and reduce errors. This includes formative and summative studies, user research, analysis, and design iterations.
* **Market Access:** Services to facilitate global market entry, including device registration, in-country representation, and obtaining necessary certifications.
* **Privacy & Security:** Consulting on data privacy and security for medical devices and IVDs, addressing compliance with regulations such as HIPAA and GDPR.
* **Regulatory Affairs & Quality Consulting:** Support for a wide range of regulatory activities, including post-market surveillance, product classification, and global registration.
* **Digital Tools:** Development and provision of digital products and software tools to simplify and automate regulatory and quality assurance activities, including regulatory monitoring and human factors engineering resources.
**Reputation / proof points**
* Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
* Provides training, tools, and resources through their human factors tool.
* Leverages software tools for digital regulatory monitoring and access to human factors engineering tools.
Emergo by UL is a regulatory consulting firm specializing in medical device and IVD compliance. They offer a comprehensive suite of services designed to support manufacturers throughout the product lifecycle.
**Expertise & scope**
* **Human Factors Engineering & Usability:** Expertise in human factors research, design, evaluation, and testing to optimize user experience and reduce errors. This includes formative and summative studies, user research, analysis, and design iterations.
* **Market Access:** Services to facilitate global market entry, including device registration, in-country representation, and obtaining necessary certifications.
* **Privacy & Security:** Consulting on data privacy and security for medical devices and IVDs, addressing compliance with regulations such as HIPAA and GDPR.
* **Regulatory Affairs & Quality Consulting:** Support for a wide range of regulatory activities, including post-market surveillance, product classification, and global registration.
* **Digital Tools:** Development and provision of digital products and software tools to simplify and automate regulatory and quality assurance activities, including regulatory monitoring and human factors engineering resources.
**Reputation / proof points**
* Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
* Provides training, tools, and resources through their human factors tool.
* Leverages software tools for digital regulatory monitoring and access to human factors engineering tools.
Additional information
Emergo by UL provides a range of digital tools and platforms to enhance regulatory and quality assurance processes. These include solutions for regulatory monitoring, e-learning, and specialized human factors engineering resources. Their services are structured to support manufacturers at every stage of the product lifecycle, from initial design and research through to market access and post-market surveillance. Buyers can expect a comprehensive approach that integrates consulting expertise with digital solutions to streamline compliance efforts.
Key Highlights
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Specializes in human factors research, design, evaluation, and testing for medical devices.
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“Optimize human factors research and design to bring medical products to market”
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Offers comprehensive medical device regulatory consulting, including market access and global registration.
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“Medical Device Market Access”
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Provides privacy and security consulting for IVD and medical device companies, addressing HIPAA and GDPR.
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“Privacy Security Consulting for Medical Device, IVD Companies”
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Develops and offers digital products and software tools to improve 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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Operates as Emergo by UL, indicating a connection to UL's broader expertise.
Source
“Emergo by UL”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking global regulatory compliance.
- Companies needing specialized support in human factors engineering and usability testing.
- Organizations looking to streamline RA/QA activities with digital tools.
How engagement typically works
- Consulting engagements tailored to specific regulatory needs.
- Provision of digital tools and platforms for ongoing compliance management.
- Support across the entire product lifecycle.
Typical deliverables
- Human factors research and design reports.
- Usability testing protocols and findings.
- Regulatory submission documentation.
- Market access strategies and support.
- Privacy and security compliance assessments.
- Digital RA/QA tools and resources.
Good to know
- Best when engaging for comprehensive regulatory support or specialized human factors expertise.
HQ:
USA
Languages:
English
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+
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, Market Access, Device Registration, Privacy & Security Consulting, Regulatory Affairs Consulting, Quality Consulting, Post-market Surveillance
Standards Supported
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance, ISO 14971
User Types Supported
Lay user, Professional healthcare
Use Environments Supported
Home healthcare, Professional healthcare
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Minimum Project Size
Custom
Pricing Model
Custom
