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Understanding The EU Medical Device Regulation For Device Companies

Europe’s new Medical Device Regulation (MDR) will have a big impact on product-development timelines. Companies must be planning now for stricter biocompatibility testing requirements, which will go into effect in May 2020. This white paper, Understanding the EU Medical Device Regulation for Device Companies, explains some of the new requirements and walks companies through the steps they need to take to ensure their products receive timely approvals in Europe.



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Nelson Laboratories, LLC

http://www.nelsonlabs.com
E: [email protected]
T: (801) 290-7500
F: (801) 290-7998

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Espergaerde, Denmark
Aa. Louis-Hansens Alle 11
Espergaerde
3060
Denmark
T +45 (0) 49 12 79 72

Gibraltar Laboratories, Fairfield, New Jersey, USA
122 Fairfield Road
Fairfield, NJ
07004-2405
United States
T (973) 227-6882

Itasca, Illinois, USA
1500 W. Thorndale Ave
Itasca, IL
60143
United States
T (630) 285-9121

Mexico City, Mexico
James Watt No. 22
Cuautitlan Izacalli
Mexico
CP 54730
Mexico
T + 52 (55) 2620 9076

Nelson Labs Europe – Leuven, Belgium
Romeinsestraat 12
Leuven
3001
Belgium
T +32 (0) 16 40 04 84

Ontario, California, USA
687 S. Wanamaker Avenue
Ontario, CA
91761
United States
T (909) 969-2302

 
 
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