Emergo by UL
Emergo by UL offers comprehensive medical device regulatory consulting, including market access, human factors, privacy, and device registration services globally.
Emergo by UL provides expert regulatory consulting for the healthcare industry, specializing in medical device and IVD compliance. Their services cover the entire product lifecycle, from initial design and human factors research to market access, privacy and security, and post-market surveillance. Leveraging extensive global expertise, Emergo by UL assists manufacturers in navigating complex regulations for international market entry. They offer specialized services such as in-country representation, device registration, and regulatory intelligence. Their digital platform and tools aim to simplify and automate regulatory affairs and quality assurance activities. Key service areas include Market Access, Human Factors Research & Design, Privacy & Security Services, Product Classification, and Device Registration. Emergo by UL is dedicated to helping clients evolve with the changing healthcare landscape and achieve global compliance.
About
**Who they are**
Emergo by UL provides comprehensive medical device regulatory consulting services, assisting manufacturers with global market access and compliance. They offer a platform of digital products to streamline regulatory activities.
**Expertise & scope**
* Market Access consulting for medical devices and IVDs.
* Human Factors Research & Design, including user research, analysis, design, evaluation, and testing.
* Privacy & Security Services addressing global compliance requirements.
* Device Registration support for global markets.
* Local Authorized Representative services for medical device manufacturers.
* Post-market surveillance.
* Regulatory Affairs and Quality Consulting.
* Development of intuitive user experiences for medical devices.
**Reputation / proof points**
* Offers a suite of digital tools including Smart Builder, RAMS® e-Learning, Registration Tracker, Regulatory Watch, Regulatory Intelligence, and Regulatory Reports.
Emergo by UL provides comprehensive medical device regulatory consulting services, assisting manufacturers with global market access and compliance. They offer a platform of digital products to streamline regulatory activities.
**Expertise & scope**
* Market Access consulting for medical devices and IVDs.
* Human Factors Research & Design, including user research, analysis, design, evaluation, and testing.
* Privacy & Security Services addressing global compliance requirements.
* Device Registration support for global markets.
* Local Authorized Representative services for medical device manufacturers.
* Post-market surveillance.
* Regulatory Affairs and Quality Consulting.
* Development of intuitive user experiences for medical devices.
**Reputation / proof points**
* Offers a suite of digital tools including Smart Builder, RAMS® e-Learning, Registration Tracker, Regulatory Watch, Regulatory Intelligence, and Regulatory Reports.
Additional information
Emergo by UL's services are designed to support medical device and IVD companies throughout the entire product lifecycle. Their offerings include tools and resources for improving, simplifying, and automating Regulatory Affairs/Quality Assurance (RA/QA) activities. They emphasize a comprehensive approach, from initial market access and human factors research to ongoing post-market surveillance and device registration. Manufacturers can leverage their expertise to navigate complex global regulations and ensure compliance.
Key Highlights
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Offers comprehensive medical device regulatory consulting, including market access, human factors, privacy, and device registration.
Source
“Emergo by UL offers comprehensive medical device regulatory consulting, including market access, human factors, privacy, and device registration services globally.”
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Provides Local Authorized Representative services for medical device manufacturers.
Source
“Local Authorized Representative for Medical Device Manufacturers”
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Specializes in Human Factors Research & Design consulting for medical devices and IVDs.
Source
“Human Factors Research & Design”
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Offers Privacy & Security Services for medical device and IVD companies.
Source
“Privacy & Security Services”
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Provides Global Medical Device & IVD Registration Consulting.
Source
“Global Medical Device & IVD Registration Consulting”
Certifications & Trust Signals
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Established expertise in navigating post-Brexit UK medical device regulations.
Source
“브렉시트 이후 의료기기 제조업체에 미치는 영향; 영국 책임자 및 공인 대리 서비스”
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Offers a suite of digital tools for regulatory management and compliance.
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 and IVD manufacturers seeking global market access.
- Companies needing specialized human factors research and design support.
- Businesses requiring assistance with device registration and regulatory compliance.
How engagement typically works
- Consulting services for regulatory affairs and quality assurance.
- Provision of digital tools and platforms for RA/QA automation.
- Support for navigating international regulatory landscapes.
Typical deliverables
- Market access strategies and execution.
- Human factors research reports and design recommendations.
- Device registration documentation and submissions.
- Privacy and security compliance assessments.
- Local Authorized Representative services.
Good to know
- Best when manufacturers require comprehensive support across multiple regulatory domains.
- Suitable for companies looking to leverage digital tools for compliance management.
HQ:
Cambridge, US
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
GBP 6,500
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
Supports NI:
Yes
Device Classes Supported:
IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
Onboarding Steps
Information available upon request from specialists.
