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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 3,000 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 expand 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

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MDR Workshop, Mar 25, 2019 to Apr 4, 2019 in Boston, MA or Fremont, USA

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Meet Emergo at FIME

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Meet Emergo at Hospitalar

China

Please contact our HK
office for more information
+852 2276 9196

Egypt

Please contact our local office
in Cairo for more information
+20 2 251 777 82

Netherlands

Prinsessegracht 20
2514 AP The Hague
+31 70 345 8570

USA

2500 Bee Cave Road
Building 1, Suite 300
Austin Texas 78746
+1 512 222 0262

Colombia

Cra 7 No. 85-93 Of. 901.
Bogotá

Egypt

9z Ahmed Kamel St., Off Laselki St.
11742 New Maadi
Cairo
+20 2 251 777 82

United Kingdom

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

United Kingdom

150, Cambridge Science Park
Milton Road
Cambridge CB4 0GN
+44 114 307 2338

South Africa

Ground Floor, Liesbeek House
River Park, Gloucester Road, Mowbray
Cape Town 7700
+27 (0)21 680 5065

Mexico

WTC, Montecito 38, Piso 34, Oficinas 35 y 36, Colonia Nápoles
Delegación Benito Juárez
Ciudad de México C.P. 03810
+52 1 55 5533 0832

Germany

Poststraβe 33
Hamburg 20354
+49 (0) 40 6094 4360

India

H.No. 8/1, First Floor, Vasavi Colony,
Kakaguda, Near Picket, Secunderabad
Hyderabad Circle – 2, Telangana 500015
+91 (0) 40 6618 0602

France

13 rue Camille Desmoulins
Issy-les-Moulineaux 92130
+33 1 58 04 27 93

Malaysia

Level 16, 1 Sentral Jalan Stesen Sentral 5
KL Sentral
Kuala Lumpur 50470
+60 3 2092 9484

Costa Rica

Edificio Ribleh 2 Piso
Diagonal a la Biblioteca Municipal
La Ribera Heredia, Belén, 40702
+ (506) 2239-0266

Peru

Calle Las Orquideas 585, Edificio Fibra
piso 13, San Isidro
Lima Lima 27
+511-712-3945

Israel

Andrei Sakharov 9
Building 25, 8th floor
Matam, North Haifa 3190501
+972 (0)775444742

Russia

Business Center West Plaza, 5th floor
Ul. Ryabinovaya, 26, building 1, Office B501
Moscow 121471
+7 (915) 110 16 32

India

Level 15, Eros Corporate Tower,
Nehru Place
New Delhi 110019
+91 (11) 6615 5325

Taiwan

10F., No.221, Sec. 3, Beixin Rd.,
Xindian Dist.,
New Taipei City 231
+886 2 2910 6575

Canada

130-13775 Commerce Parkway
Richmond British Columbia V6V 2V4
+1 604 909 1265

Brazil

Avenida Francisco Matarazzo 1.752
Salas 502/503, Água Branca
São Paulo São Paulo CEP – 05001-200
+55 61 3386 3166

South Korea

26th Floor, Gangnam Finance Center
152, Teheran-ro, Gangnam-gu,
Seoul 06236
+82-2-2009-9283

Hong Kong

18th Floor, Delta House
3 On Yiu Street
Shatin, NT HONG KONG
+852 2276 9196

Singapore

1 Fusionopolis Walk
#10-01 Solaris South Tower
Singapore 138628
+65 6854 7976

Australia

201 Sussex Street
Darling Park, Tower II, Level 20
Sydney New South Wales 2000
+61 2 9006 1662

Japan

Marunouchi Trust Tower Main Building 6F
1-8-3 Marunouchi, Chiyoda-ku,
Tokyo 100-0005
+81 3 5293 6670