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Colombia

Market Access
Cra 6 No. 91-35 of 804
Bogotá 110221
Tel: 571 7186969
Customer Service Tel: 313 441 9785
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Greater China Region

Market Access
Room 8B, 11/F, Tower W3 No. 1, East Chang'an Avenue Dongcheng District Beijing, 100738
Beijing City 100022
+86 021 61376300 (Shanghai) +86 (020) 32131000 (Guangzhou), +86 (010) 85277100 (Beijing)
Contact:
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Market Access
18th Floor, Delta House
3 On Yiu Street
Shatin, NT HONG KONG New Territories
Contact:
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Market Access
10F., No.221, Sec. 3, Beixin Rd., Xindian Dist.,
New Taipei City TPE 231
Tel: +886 2 7737 7500
Contact:
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Post-Market Clinical Follow-up (PMCF) Studies Under the EU MDR

In this white paper, learn about PMCF studies in the context of the change from the current Medical Devices Directive 93/42/EU (MDD) to the new Medical Devices Regulation (MDR 2017/745/EU).

Brazil

Market Access
Avenida Francisco Matarazzo 1.752, Salas 502/503
Água Branca
São Paulo - SP CEP – 05001-200
Tel: +55 11 4800 9226
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European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices

Emergo assists medical device manufacturers with post-market clinical follow-up (PMCF) studies, investigations, clinical trial management, data validation and more.

Australia

Market Access
201 Sussex Street
Darling Park, Tower II, Level 20
Sydney NSW 2000
Tel: +61 2 9006 1662
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RAMS® - 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.

South Korea

Market Access
26th Floor, Gangnam Finance Center
152, Teheran-ro, Gangnam-gu
Seoul 06236
Tel: +82-2-2009-9283
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EU IVDR Readiness Assessment Checklist

This brief checklist will help you to determine how to bring your in vitro diagnostic medical device company into compliance with the EU IVDR.

European Authorized Representative for Medical Device and IVD Companies

European authorized representative (EC REP) for medical device and IVD companies. Official EU Authorized Representative for 1,000+ manufacturers worldwide.