Emergo by UL (Importer/Distributor MDR Webinar)
Emergo by UL
Emergo by UL offers comprehensive regulatory consulting and compliance services for medical devices and IVDs. They specialize in market access, human factors, privacy, security, and device registration globally.
Emergo by UL provides expert regulatory consulting and compliance solutions tailored for medical device and IVD manufacturers navigating global markets. Their services encompass market access strategies, human factors research and design, privacy and security consulting (including HIPAA and GDPR), and end-to-end device registration support. Leveraging extensive expertise, Emergo by UL assists clients with in-country representation, post-market surveillance, and regulatory affairs management. They offer digital tools and platforms to streamline regulatory activities, enhance compliance, and provide access to critical industry insights. Their offerings are designed to help companies evolve with the changing healthcare landscape and achieve successful product launches worldwide.
About
**Who they are**
Emergo by UL (Importer/Distributor MDR Webinar) provides comprehensive regulatory consulting and compliance services tailored for medical device and IVD companies. They focus on enabling market access and ensuring adherence to global regulations.
**Expertise & scope**
* Market Access
* Human Factors Research & Design
* Privacy & Security Services (including HIPAA and GDPR)
* Product Classification
* Regulatory Affairs Consulting
* Device Registration
* In-country Representation
* Post-market Surveillance
* Software development consulting
* Global regulatory M&A services
* Gap analysis for EU MDD to MDR transition
* IVDD to IVDR Gap Analysis
* UK Responsible Person (UKRP) services post-Brexit
* CE Marking Strategy for Medical Devices
* Clinical Evaluation Reports (CER)
**Reputation / proof points**
* Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
* Provides digital regulatory monitoring for medical device compliance and access to human factors engineering tools.
Emergo by UL (Importer/Distributor MDR Webinar) provides comprehensive regulatory consulting and compliance services tailored for medical device and IVD companies. They focus on enabling market access and ensuring adherence to global regulations.
**Expertise & scope**
* Market Access
* Human Factors Research & Design
* Privacy & Security Services (including HIPAA and GDPR)
* Product Classification
* Regulatory Affairs Consulting
* Device Registration
* In-country Representation
* Post-market Surveillance
* Software development consulting
* Global regulatory M&A services
* Gap analysis for EU MDD to MDR transition
* IVDD to IVDR Gap Analysis
* UK Responsible Person (UKRP) services post-Brexit
* CE Marking Strategy for Medical Devices
* Clinical Evaluation Reports (CER)
**Reputation / proof points**
* Offers a platform of digital products to improve, simplify, and automate RA/QA activities.
* Provides digital regulatory monitoring for medical device compliance and access to human factors engineering tools.
Additional information
Emergo by UL's service offerings span the entire product lifecycle, from initial design and research through to market access and post-market surveillance. They emphasize digital tools and platforms to streamline regulatory and quality assurance processes. Buyers can leverage their expertise for navigating complex regulatory landscapes such as the EU MDR and IVDR, as well as specific regional requirements like the UK Responsible Person post-Brexit. Their services also extend to privacy and security consulting, addressing critical data protection needs within the healthcare industry.
Key Highlights
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Specializes in regulatory consulting for medical devices and IVDs, covering market access, human factors, privacy, security, and global device registration.
Source
“Emergo by UL offers comprehensive regulatory consulting and compliance services for medical devices and IVDs.”
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Provides services to address compliance with global security and privacy requirements, including HIPAA and GDPR.
Source
“address compliance with global security and privacy requirements”
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Offers expertise in navigating the EU MDD to MDR transition and IVDD to IVDR gap analysis.
Source
“Gap Analysis: EU MDD to MDR for Medical Device CE Marking”
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Provides UK Responsible Person (UKRP) services for medical devices post-Brexit.
Source
“UK Responsible Person (UKRP) for Medical Devices”
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 software tools for 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.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking global market access.
- Companies navigating complex regulatory transitions, such as EU MDR/IVDR.
- Organizations requiring specialized support in privacy, security, and human factors.
How engagement typically works
- Project-based consulting for specific regulatory needs.
- Ongoing support for regulatory monitoring and compliance.
- Leveraging digital tools for RA/QA automation.
Typical deliverables
- Regulatory strategy and planning documents.
- Gap analysis reports and transition plans.
- Clinical Evaluation Reports (CER).
- UK Responsible Person (UKRP) services.
- Market access documentation and support.
Good to know
- Best when buyers require specialized expertise in medical device and IVD regulations.
- Most effective for companies aiming for compliance in the EU and UK markets.
HQ:
Amsterdam, US
Languages:
English
Timezones:
Europe/Amsterdam
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU
Countries:
NL, DE, FR, IT, ES, BE
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
26-100, 100+
Onboarding time:
4–12 days
Pricing model:
Retainer
Starting from:
EUR 2,500
Included services:
Importer/Distributor SOP & template pack, Training for economic operator obligations, Compliance gap scan, Audit readiness support, Ongoing compliance support
Training Available:
Yes
Template Pack Available:
No
Deliverables:
Training
Training Format:
Both
Role Coverage:
Both
Additional importer_distributor_compliance Details
Role Coverage
Importer, Distributor
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Implied through market access and gap analysis services
Device Classes Supported
Not explicitly stated, but services cover medical devices and IVDs generally.
Storage Conditions Support
Not explicitly stated.
Onboarding Steps
Not explicitly stated.
