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
- Map
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.
MDR Resource Center for Medical Device Manufacturers
Emergo by UL's MDR resource center offers support for medical device manufacturers transitioning from MDD to comply with EU's MDR for CE Marking.
IVDR Resource Center for IVD Manufacturers
Resources, news, and services from Emergo by UL to help IVD manufacturers comply with the EU's In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).