Emergo by UL
Emergo by UL offers comprehensive regulatory consulting and human factors expertise for medical device and IVD companies seeking global market access. They provide services for compliance, registration, privacy, and security.
Emergo by UL is a specialized provider of regulatory consulting services for the medical device and In Vitro Diagnostic (IVD) industries. They assist companies in navigating complex global market access requirements, ensuring compliance with various regulatory bodies. Their expertise spans critical areas such as medical device registration, human factors research and design, privacy and security consulting (including HIPAA and GDPR), and post-market surveillance. Leveraging a deep understanding of the evolving healthcare landscape, Emergo by UL offers a platform of digital products and tools designed to simplify and automate Regulatory Affairs/Quality Assurance (RA/QA) activities. This includes solutions for regulatory monitoring, human factors engineering, and compliance tracking. They also provide in-country representation and support for obtaining necessary certifications like Certificates of Free Sale. With a focus on enabling innovation and simplifying compliance, Emergo by UL empowers manufacturers to bring their products to market efficiently and securely. Their services are tailored to address the specific needs of device manufacturers, from initial product classification and development through to ongoing market surveillance and regulatory intelligence.
About
**Who they are**
Emergo by UL provides comprehensive regulatory consulting and human factors expertise for medical device and IVD companies. They focus on enabling global market access for their clients.
**Expertise & scope**
* **Market Access:** Facilitating entry into global markets for medical devices and IVDs.
* **Regulatory Affairs & Quality Consulting:** Offering support for compliance, registration, and post-market surveillance.
* **Human Factors Research & Design:** Providing training, tools, and resources to optimize user experience and reduce errors.
* **Privacy & Security:** Addressing global security and privacy requirements, including HIPAA and GDPR.
* **Device Registration:** Assisting with medical device and IVD registration processes by country.
* **Local Authorized Representative Services:** Acting as a representative for medical device manufacturers.
* **Digital Tools:** Offering a platform of digital products for regulatory monitoring, RA/QA automation, and human factors engineering.
**Reputation / proof points**
* Offers a suite of digital products including Smart Builder, RAMS® e-Learning, Registration Tracker, Regulatory Watch, Regulatory Intelligence, and Regulatory Reports.
Emergo by UL provides comprehensive regulatory consulting and human factors expertise for medical device and IVD companies. They focus on enabling global market access for their clients.
**Expertise & scope**
* **Market Access:** Facilitating entry into global markets for medical devices and IVDs.
* **Regulatory Affairs & Quality Consulting:** Offering support for compliance, registration, and post-market surveillance.
* **Human Factors Research & Design:** Providing training, tools, and resources to optimize user experience and reduce errors.
* **Privacy & Security:** Addressing global security and privacy requirements, including HIPAA and GDPR.
* **Device Registration:** Assisting with medical device and IVD registration processes by country.
* **Local Authorized Representative Services:** Acting as a representative for medical device manufacturers.
* **Digital Tools:** Offering a platform of digital products for regulatory monitoring, RA/QA automation, and human factors engineering.
**Reputation / proof points**
* Offers a suite of digital products including Smart Builder, RAMS® e-Learning, Registration Tracker, Regulatory Watch, Regulatory Intelligence, and Regulatory Reports.
Additional information
Emergo by UL emphasizes a comprehensive approach to product lifecycle management, from initial design and human factors research to market access, registration, and post-market surveillance. Their services are supported by a platform of digital tools designed to simplify and automate regulatory affairs and quality assurance activities. They also highlight their expertise in privacy and security consulting, crucial for navigating global compliance requirements like HIPAA and GDPR. For manufacturers seeking a local presence, their authorized representative services are a key offering.
Key Highlights
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Provides Local Authorized Representative services for medical device manufacturers.
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“Local Authorized Representative for Medical Device Manufacturers”
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Offers comprehensive regulatory consulting for medical device and IVD market access.
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“Medical Device Market Access”
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Specializes in Human Factors Research & Design consulting for medical products.
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“Human Factors Research & Design”
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Provides Privacy & Security Services for medical device and IVD companies.
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“Privacy Security Consulting for Medical Device, IVD Companies”
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Assists with global medical device and IVD registration consulting.
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“Global Medical Device & IVD Registration Consulting”
Certifications & Trust Signals
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Offers a platform of digital products to improve, simplify and automate RA/QA activities.
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“A platform of digital products to improve, simplify and automate RA/QA activities”
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Provides software tools for digital regulatory monitoring and human factors engineering access.
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“Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.”
Buyer Snapshot
Best for
- Medical device and IVD companies seeking global market access.
- Companies needing regulatory consulting for registration and compliance.
- Manufacturers requiring human factors research and design expertise.
- Businesses needing support with privacy and security compliance.
How engagement typically works
- Consulting services for regulatory affairs and quality assurance.
- Provision of digital tools for regulatory monitoring and automation.
- Acting as a local authorized representative.
- Training and resources for human factors engineering.
Typical deliverables
- Market access strategies and support.
- Regulatory registration documentation.
- Human factors research reports and design recommendations.
- Privacy and security compliance assessments.
- Post-market surveillance plans.
- Digital regulatory monitoring tools.
Good to know
- Best when requiring specialized expertise in medical device and IVD regulations.
- Suitable for companies navigating complex international market entry.
- Ideal for those looking to leverage digital tools for compliance efficiency.
HQ:
Austin, US
Languages:
English
Timezones:
America/New_York
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVDs
Portfolio:
6-25, 26-100, 100+
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 2,200
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders
Registration Support:
Yes
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Export Certificate, Regulatory Consulting, Training/Education
Additional us_agent_fda Details
Product Types
Medical Devices, IVDs
Registration Support
Yes
Recall Support
Yes (Post-market surveillance)
