European Union

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We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

Certificate of Free Sale (CFS) for Medical Device Exports

Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries around the world.

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Choose Your Path for Market Growth.

Scalable RA/QA SaaS solution for medical device and IVD manufacturers

Customized Regulatory Pathway Reports for Smaller International Markets

In most major markets the path to medical device regulatory approval is well documented. The process may not be easy, but it is well understood. That’s not true in all countries, especially some countries in Latin America, Southeast Asia, Africa and the Mi

European CE Marking for In Vitro Diagnostic (IVD) Medical Devices

ANSWERED ON THIS PAGE:

What is the regulatory process for IVDs in Europe?
What is the European classification scheme for IVDs?
How will IVD requirements change under the new In-Vitro Diagnostic Regulation (IVDR)?

US FDA rolls out notification requirements to protect medical device supply chains

European CE Technical Documentation for Medical Devices

We help medical device and IVD companies prepare Technical Files and Design Dossiers to obtain CE Marking. Learn more about our Techincal File services.

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ISO 13485 Audits for Medical Device Companies

The purpose of quality audits is to verify that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.

ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ANSWERED ON THIS PAGE:

Why do we need ISO 13485 certification?
How will ISO 13485 certification benefit our company?
What is involved in the implementation process?

ISO 14971 Risk Management Consulting for Medical Device Companies

ANSWERED ON THIS PAGE:

What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?

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ISO 14971 Risk Management Training for Medical Device Companies

Learn about Emergo by UL's ISO 14971 risk management training courses for medical device companies.

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IVDR Gap Assessment and CE Transition Strategy for IVDs

Emergo by UL can help you transition from IVDD to IVDR by conducing a systematic, independent gap analysis to help you comply with the EU IVDR.

Gap Assessment and CE Transition Strategy for Medical Device Manufacturers

MDR Gap Assessments and CE Transition Strategies

Emergo by UL's EU MDD to MDR 2017/745 gap analysis and strategy recommendations can help you make a smooth transition and avoid unforeseen challenges.

Medical Device Single Audit Program (MDSAP) Internal and Gap Audits

ANSWERED ON THIS PAGE:

What are the requirements for the Medical Device Single Audit Program (MDSAP)?
Which countries are participating in the MDSAP?
How can we achieve MDSAP certification?

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QMS Compliance for Startup Medical Device Companies

Startups need a quality management system (QMS) for medical devices well before products are shipped. Emergo can help you comply with US FDA and European regulations so you don't run into problems during registration.

Regulatory Affairs Management Suite

RAMS can help you navigate complex medical device and IVD regulatory affairs activities with powerful tools to simplify your work and provide market insights.

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Short Term or Part-time Medical Device QA/RA Outsourcing

Emergo provides short term quality assurance (QA) and regulatory affairs (RA) outsourcing for assistance with medical device registrations, QMS compliance, vigilance reporting and more.

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Simplify Regulatory Documentation with Smart Builder

Smart Builders walk you through regulatory documentation for Brazil’s Registro Route, Mexico Equivalency Routes, US FDA 510(k), and Europe’s MDD, MDR, and IVDR.

Tap into Strategic Knowledge with Regulatory Intelligence.

Plan your expansion with process charts and FAQs comprising a global knowledge base.

UK Responsible Person and Brexit Consulting for Medical Device Companies

Emergo by UL offers UK Responsible Person (UKRP), Brexit transition consulting and in-country representation for medical device and IVD companies.

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