Emergo by UL
Emergo by UL offers comprehensive regulatory consulting and human factors expertise for global medical device market access. They specialize in IVDR compliance, device registration, and privacy/security consulting.
Emergo by UL provides specialized regulatory consulting services to help medical device and IVD companies navigate global market access. Their expertise spans across critical areas such as IVDR compliance, device registration in various countries, and post-market surveillance. They also offer in-depth human factors research and design, privacy and security consulting to ensure adherence to regulations like HIPAA and GDPR, and software solutions to streamline regulatory affairs and quality assurance activities. With a focus on the evolving healthcare industry, Emergo by UL leverages its global team and digital tools to simplify and automate RA/QA processes. Their services are designed to support manufacturers throughout the entire product lifecycle, from initial design and development to market entry and ongoing compliance. They are a valuable partner for companies seeking to ensure their medical devices meet international regulatory standards and reach their target markets efficiently.
About
**Who they are**
Emergo by UL is a regulatory consulting firm specializing in global medical device market access. They offer comprehensive expertise across the product lifecycle, including regulatory affairs, quality consulting, and human factors engineering.
**Expertise & scope**
* Regulatory consulting for medical devices and IVDs
* Device registration and global market access
* In-country representation services
* Post-market surveillance
* Privacy and security consulting, including HIPAA and GDPR compliance
* Human Factors Research & Design (HFR&D) services, including user research, analysis, design, and testing
* Software development consulting
* Regulatory intelligence and monitoring
* Support for obtaining Certificates of Free Sale (CFS) and Certificates to Foreign Government (CFG) from FDA
**Reputation / proof points**
* Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
* Provides training, tools, and resources for human factors engineering.
Emergo by UL is a regulatory consulting firm specializing in global medical device market access. They offer comprehensive expertise across the product lifecycle, including regulatory affairs, quality consulting, and human factors engineering.
**Expertise & scope**
* Regulatory consulting for medical devices and IVDs
* Device registration and global market access
* In-country representation services
* Post-market surveillance
* Privacy and security consulting, including HIPAA and GDPR compliance
* Human Factors Research & Design (HFR&D) services, including user research, analysis, design, and testing
* Software development consulting
* Regulatory intelligence and monitoring
* Support for obtaining Certificates of Free Sale (CFS) and Certificates to Foreign Government (CFG) from FDA
**Reputation / proof points**
* Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
* Provides training, tools, and resources for human factors engineering.
Additional information
Emergo by UL provides a suite of digital tools designed to streamline regulatory affairs and quality assurance processes. These 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. They emphasize adapting to the evolving healthcare industry landscape.
Key Highlights
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Specializes in IVDR compliance, device registration, and privacy/security consulting.
Source
“They specialize in IVDR compliance, device registration, and privacy/security consulting.”
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Offers comprehensive regulatory consulting and human factors expertise for global medical device market access.
Source
“Emergo by UL offers comprehensive regulatory consulting and human factors expertise for global medical device market access.”
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Provides services including market access, human factors research & design, and privacy & security services.
Source
“Market Access Human Factors Research & Design Privacy & Security Services”
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Offers 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.”
Certifications & Trust Signals
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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 training, tools, and resources for human factors engineering.
Source
“Emergo by UL's new human factors tool - provides training, tools, and resources.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking global market access
- Companies needing IVDR compliance support
- Firms requiring specialized human factors consulting
How engagement typically works
- Project-based consulting
- Ongoing regulatory support
Typical deliverables
- Regulatory strategy and submissions
- Market access plans
- Human factors research reports
- Privacy and security compliance assessments
Good to know
- Best when requiring comprehensive regulatory and quality support for medical devices and IVDs.
HQ:
Zurich, USA
Languages:
English, German, French
Timezones:
Europe/Zurich
Status:
listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
100+
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Swiss Local Contact:
Yes
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
The provided content does not detail specific onboarding steps, required documents, timelines, or setup procedures.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
All
Supports MDR
true
Supports IVDR
true
Swiss Entity Canton Or Region
CH
Labeling Support
true
Swiss Local Contact
true
Vigilance Contact Support
true
Can Be Named On Label
true
