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Emergo by UL logo

         

Market Compliance Consulting

Emergo has been helping medical device and IVD companies with regulatory compliance and market entry since 1997. After the implementation of the new European Medical Devices Directive (93/42/EEC), US medical device companies needed help obtaining CE Marking and exporting their products to Europe. Emergo was there to bridge the gap.

Since then, we have become a leading consultancy with more than 2,800 medical device and IVD clients worldwide. We maintain offices in 25+ countries, offering a wide range of compliance services, including regulatory strategy, device registration, quality management system compliance, and in-country regulatory representation. We offer our clients a single source for regulatory compliance help, whether they are selling in one market or dozens of countries around the world. The size of our global team means we have deep expertise with a variety of market requirements and device types. Want to know why so many device companies choose Emergo? Learn more about our unique approach to helping you expland your market reach.

7 Reasons to Choose Emergo

 

1. We Can Help You Access Markets More Efficiently

Brazil, China, Japan, Mexico, Korea...which market is next for you? We help medical device manufacturers strategically leverage their existing regulatory approvals so they can enter new markets quickly and cost effectively. Hiring an experienced consultant with a global view and local expertise is critical. While we cannot control how fast Ministries of Health review registration applications, we'll do everything we can to get you in line for approval as quickly as possible.


 

2. One Call Gets You Access To 95% Of The Global Medical Device Market

There are hundreds of qualified consultants who can help you with compliance in one or two markets. Emergo can help you prioritize and access more than 55 countries accounting for 95% of the global healthcare spending. Our experienced consultants in 30 countries have local market intelligence, established industry contacts and knowledge of local business customs. In many cases, having this local expertise is the difference between success and frustration. There is no need for you to hire multiple consulting firms or entrust your registrations to numerous distributors or unaffiliated consultants. "One call. One trusted partner. Worldwide access."

 


 

3. We Have Experience With Numerous Devices

We serve thousands of medical device and IVD clients making a huge variety of products. Chances are very good that our consulting team has experience with your specific device or the category. Our consulting expertise runs especially deep in areas such as orthopedics, cardiovascular, dental, radiology, wound care and IVDs.

 


 

4. We Give You Full Control Over How You Distribute Your Devices

Don't get stuck with a poorly performing distributor because they control your registration in a specific market. More than 2,000 companies use us as their independent regulatory representative and registration holder. We have no involvement in selling products so using Emergo as your regulatory representative allows you to bring on new distributors as you wish, and terminate those who do not perform. This is important in markets including Europe, Brazil, Japan, Mexico and China.

 


 

5. Your Intellectual Property Is Safe With Us

Do you trust your distributor with your intellectual property? It's an especially critical issue for new and innovative technology. Emergo has nothing to gain by sharing your IP. Others might. When you work with us, your documents, manuals, certificates, dossiers and project related files are made available on a secure, password protected web-based platform accessible only to employees and key consultants working on your project. Your data is confidential and none of it is stored on desktop computers where it could be lost or stolen. Plus, everyone working on your project has access to the same updated information online.

 


 

6. We Provide Accurate, Realistic Project Budgets

Nobody likes surprises when it comes to invoices. Our consultants all carefully track the number of hours spent on each project and use this knowledge to more accurately estimate new projects. Barring unforeseen complications, the majority of our projects finish within the original budget and you only pay for the hours we spend on your project.

 


 

7. We Provide Frequent Updates And Peer Review All Projects

We have dedicated project management teams in North and South America, Europe and Asia. They all use the same project management platform. Our teams provide frequent updates on projects so you know expected time to completion, and the remaining budget. Plus, we always have a "fresh set of eyes" examine all prepared documents for quality, accuracy and completeness before they are sent to a client. All departments have documented work procedures, and yearly audits, peer reviews and client surveys help us improve ongoing efficiency. Independent consultants and distributors rarely offer this level of quality control.

 


 

Questions? Request more information from our specialists

CONTACT US >

REGISTER NOW: Round Table for Medical Devices, Nov 22, 2018 to Nov 22, 2018 in Cambridge, United Kingdom

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Market Compliance Consulting

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Egypt | Market Compliance Consulting

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QMS Compliance for Startup Medical Device Companies

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European CE Marking Strategy for Medical Devices

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Biostatistics for Medical Device Clinical Studies

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Medical Device Clinical Trial Management and Monitoring

Europe | Market Compliance Consulting

CE Mark Training for EU Medical Device Regulations

Hong Kong | Market Compliance Consulting

Medical Device Registration in Hong Kong

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Hong Kong Medical Device Regulatory Strategy Report

India | Market Compliance Consulting

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India CDSCO Medical Device Registration and Approval

Israel | Market Compliance Consulting

Israel Medical Device Strategy Report

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Israel Registration Holder for Device and IVD Companies

Israel | Market Compliance Consulting

Medical Device Registration and Approval in Israel

Japan | Market Compliance Consulting

PMDA Registration for In-Vitro Diagnostics (IVDs) in Japan

Japan | Market Compliance Consulting

Japan Medical Device Regulatory Strategy Report

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PMDA Medical Device Registration and Approval in Japan

Malaysia | Market Compliance Consulting

Medical Device Registration in Malaysia

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Malaysia Medical Device and IVD Regulatory Strategy Report

Mexico | Market Compliance Consulting

Medical Device Vigilance Reporting in Mexico

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Classification of Medical Devices in Mexico

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Mexico Registration Holder for Imported Medical Devices

New Zealand | Market Compliance Consulting

MedSafe Medical Device Registration in New Zealand

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New Zealand Medical Device and IVD Regulatory Strategy Report

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New Zealand Sponsor Representation for Medical Device Companies

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Peru Registration Holder (PRH) in-country representation

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Medical Device Registration and Approval in Peru

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Peru Medical Device Strategy Report

Russia | Market Compliance Consulting

Russia Medical Device and IVD Regulatory Strategy Report

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Medical Device and IVD Registration in Russia

Saudi Arabia | Market Compliance Consulting

Saudi Arabia Authorized Representative for Device Companies

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Medical Device Registration and Approval in Saudi Arabia

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Saudi Arabia Regulatory Strategy Report

Singapore | Market Compliance Consulting

Singapore Vigilance Reporting for Medical Devices

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Classification of Medical Devices in Singapore

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Singapore Registrant Representation for Medical Device Companies

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Medical Device Registration and Approval in Singapore

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Singapore Medical Device Regulatory Strategy Report

South Africa | Market Compliance Consulting

South Africa Medical Device Regulatory Strategy Report

South Korea | Market Compliance Consulting

South Korea Medical Device Vigilance Reporting

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South Korea Medical Device Classification

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South Korea Medical Device Regulatory Strategy Report

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Technical File Preparation for Korea MFDS Submissions

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South Korea MFDS (KFDA) Medical Device Registration and Approval

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South Korea KGMP Quality Management System Consulting

Taiwan | Market Compliance Consulting

Medical Device Vigilance Reporting in Taiwan

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Taiwan Agent Representation for Medical Device Companies

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Medical Device Registration and Approval in Taiwan

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Taiwan Medical Device Regulatory Strategy Report

United States | Market Compliance Consulting

US FDA Official Correspondent for Medical Device Companies

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FDA eMDR Adverse Event Reporting for Medical Device Companies

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FDA Submission for Medical Devices and In Vitro Diagnostics (IVDs)

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US FDA Medical Device Classification

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US FDA Medical Device Establishment Registration and FURLS Listing

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US FDA Consulting for Medical Device and IVD Manufacturers

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US FDA Pre-Sub (Q-Sub) Consulting for Medical Devices

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Medical Device Design, Process and Software Validation Services

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FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers

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FDA QSR Training (21 CFR Part 820) for Medical Device Companies

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US FDA Form 483 and Warning Letter Analysis, Response, and Recovery

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US FDA Agent Representation for Medical Device and IVD Companies

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US FDA 510(k) Consulting for Medical Devices and IVDs

Worldwide | Market Compliance Consulting

IVD Registration and Approval Consulting

Worldwide | Market Compliance Consulting

Wireless Compliance Consulting for Medical Device Companies

Worldwide | Market Compliance Consulting

Global Regulatory Strategy and Country Reports

Worldwide | Market Compliance Consulting

QA & RA Due Diligence Audits for Medical Device M&A

Worldwide | Market Compliance Consulting

On-Site Regulatory Training for Medical Device Companies

Market Compliance Consulting

Meet Emergo at FIME

Market Compliance Consulting

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Meet Emergo at KIMES

United Kingdom

150, Cambridge Science Park
Milton Road
Cambridge CB4 0GN
+44 (0)1223 214 044

USA

205 W Wacker Drive
Floor 13, Suite 1300
Chicago Illinois 60606
847 664 1363

USA

300 Baker Avenue
Suite 200
Concord Massachusetts 01742
978 371 2700

Netherlands

Arthur van Schendelstraat 600-G
MJ Utrecht,
The Netherlands 3511
+31 263 764 985

Japan

Marunouchi Trust Tower Main Building 6F
1-8-3 Marunouchi, Chiyoda-ku,
Tokyo 100-0005
+81 3 5293 6041