Emergo by UL
Emergo by UL offers comprehensive regulatory consulting and human factors expertise for global market access in the medical device and IVD industries. They specialize in navigating complex regulations like EU MDR and IVDR, providing digital tools and services to simplify compliance.
Emergo by UL is a specialized provider of regulatory consulting and human factors expertise, dedicated to helping medical device and IVD manufacturers achieve global market access. They offer a comprehensive suite of services designed to navigate the complexities of international regulations, including the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Their offerings span the entire product lifecycle, from initial design and development to post-market surveillance. Key services include market access strategies, human factors research and design, privacy and security services, product classification, and regulatory intelligence. Emergo by UL also provides specialized consulting for M&A regulatory due diligence, software development lifecycle compliance, and gap analysis between different regulatory frameworks (e.g., EU MDD to MDR). Leveraging a platform of digital products and tools, Emergo by UL aims to improve, simplify, and automate regulatory and quality assurance (RA/QA) activities. This includes their human factors tool, digital regulatory monitoring software, and resources for staying informed on the latest industry news and insights. They are committed to helping clients evolve with the changing healthcare industry and ensure compliance with evolving global standards.
About
**Who they are**
Emergo by UL provides comprehensive regulatory consulting and human factors expertise for global market access within the medical device and IVD industries. They specialize in navigating complex regulations such as EU MDR and IVDR.
**Expertise & scope**
* Navigating complex regulations like EU MDR and IVDR.
* Providing digital tools and services to simplify compliance.
* Offering regulatory consulting and human factors expertise.
* Supporting global market access for medical devices and IVDs.
* Specializing in privacy and security consulting for medical device and IVD companies.
* Assisting with device registration globally.
* Providing post-market surveillance.
* Offering human factors research and design services, including user research, analysis, design, evaluation, and testing.
* Developing intuitive medical device user experiences to reduce errors.
* Providing regulatory intelligence and monitoring.
**Reputation / proof points**
* Operates offices in multiple locations.
* Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
* Provides digital regulatory monitoring for medical device compliance.
Emergo by UL provides comprehensive regulatory consulting and human factors expertise for global market access within the medical device and IVD industries. They specialize in navigating complex regulations such as EU MDR and IVDR.
**Expertise & scope**
* Navigating complex regulations like EU MDR and IVDR.
* Providing digital tools and services to simplify compliance.
* Offering regulatory consulting and human factors expertise.
* Supporting global market access for medical devices and IVDs.
* Specializing in privacy and security consulting for medical device and IVD companies.
* Assisting with device registration globally.
* Providing post-market surveillance.
* Offering human factors research and design services, including user research, analysis, design, evaluation, and testing.
* Developing intuitive medical device user experiences to reduce errors.
* Providing regulatory intelligence and monitoring.
**Reputation / proof points**
* Operates offices in multiple locations.
* Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
* Provides digital regulatory monitoring for medical device compliance.
Additional information
Emergo by UL offers a suite of digital tools designed to streamline regulatory affairs and quality assurance (RA/QA) activities. These tools include solutions for regulatory monitoring, registration tracking, and access to human factors engineering resources. Their services cover the entire product lifecycle, from initial design and development through market access and post-market surveillance. Buyers can expect support in addressing global security and privacy requirements, as well as navigating specific regulatory frameworks like the EU MDR and IVDR. The company emphasizes simplifying compliance through digital solutions and expert consulting.
Key Highlights
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Specializes in navigating complex regulations like EU MDR and IVDR.
Source
“Navigating EU's Medical Devices Regulation 2017/745 (MDR)”
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Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
Source
“A platform of digital products to improve, simplify and automate RA/QA activities”
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Provides comprehensive regulatory consulting and human factors expertise for global market access.
Source
“Regulatory consulting for medical devices and IVDs”
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Offers privacy and security consulting services tailored for IVD and medical device companies.
Source
“Data privacy consulting services”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking global market access.
- Companies needing assistance with complex EU regulations (MDR/IVDR).
- Organizations looking for integrated regulatory and human factors support.
How engagement typically works
- Consulting services for regulatory strategy and compliance.
- Provision of digital tools for RA/QA automation.
- Support for device registration and market entry.
- Expertise in human factors research and design.
Typical deliverables
- Regulatory compliance strategies.
- Device registration documentation.
- Human factors research reports.
- Digital RA/QA tools and platforms.
- Post-market surveillance plans.
Good to know
- Best when requiring specialized expertise in medical device and IVD regulations.
- Ideal for companies aiming to simplify complex compliance processes.
HQ:
Amsterdam, USA
Languages:
English
Timezones:
Europe/Amsterdam
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU, UK
Countries:
NL, BE, DE, FR, IE, ES, IT, SE
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 9,000
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD
Post Market Support:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
No
Alternate Names:
Emergo
Labeling Review:
No
Can Be Named On Label:
No
Additional eu_ar Details
Supports MDR
Yes
Supports IVDR
Yes
Fsca Recall Support
Not explicitly stated
Post Market Support
Yes
Vigilance Contact Support
Not explicitly stated
Device Classes Supported
Not explicitly stated
Onboarding Steps
Not explicitly stated
EU Entity Country
Not explicitly stated
