World-class medical device testing laboratory, Nelson Laboratories, announces expanded service to medical device manufacturers in Europe, Israel, and Turkey. This expansion demonstrates Nelson’s commitment to servicing this important region by offering international medical device manufacturers localized access to Nelson Labs’ testing and consulting services, and regulatory expertise.
SALT LAKE CITY, UT – August 11, 2015 – Nelson Laboratories, of Salt Lake City, UT, USA, announced today a strategic partnership with MedNet GmbH, of Münster, Germany, to meet the needs of its growing medical device manufacturing clients in Europe, Israel, and Turkey. Nelson Labs is dedicated to providing these expanding international markets additional testing and consulting support, and partnership with MedNet demonstrates that commitment. MedNet, a sales support organization, brings 25 years of regional customer service and sales experience to Nelson Labs’ international presence.
“Partnership with MedNet allows us to serve our international customers on a more personalized level,” said Jeffery R. Nelson, Nelson Laboratories President/CEO. “Manufacturers expanding into global markets will benefit from our strong regulatory reputation and service-oriented approach. Our partnership with MedNet will also improve our international customers’ device development and market introduction timelines, and provide additional regulatory support. This ensures our client’s life-changing medical technologies make it to market faster, saving more lives. This is our mission, to help improve the quality of life.”
Nelson Labs has served the global MedTech market for the last three decades, but its partnership with MedNet represents the first time Nelson Labs has had a physical support presence dedicated to servicing Europe, Israel, and Turkey.
Nelson Labs’ testing services for this region include:
Toxicological risk assessments, chemical and material characterization, including leachables and extractables studies, and biocompatibility testing for in vivo and in vitro test models
Testing medical device products in porous, nonporous, and tray configurationsSterilization Validations (ISO 11135 & ISO 11137):
Ethylene Oxide (EO) and Radiation, respectively, of single use devicesReprocessing of Reusable Medical Devices (ISO 17664, ISO 17665, AAMI TIR 12, TIR 30, & TIR 34, & related US FDA guidance):
Cleaning, disinfection, and sterilization assessments to support manufacturer cleaning instructions and label claimsCleanliness Assessments (ISO NP 19227 & ASTM F2847):
Newly manufactured device cleanliness assessments for orthopedic and implant devicesBarrier Performance Testing (ISO 16603, ISO 16604, & AAMI PB70, & EN 14683):
Medical and surgical gowns, drapes, and face masks
The partnership with MedNet also extends international access to Nelson Laboratories’ Technical Consulting. Consulting services for this region include:
– Written justifications for test selection
– Sampling plans
– Protocol outlines
– Onsite assessments
– Regulatory support for U.S. FDA 510(k), PMA, and EU CE mark regulatory submissions, directly and through qualified third-party regulatory consultants
Visit www.nelsonlabs.com to learn more about the Nelson Labs/MedNet partnership.
About Nelson Laboratories: Established in 1985, Nelson Laboratories is a leading provider of testing and consulting services. We know that every test matters and requires solutions that improve patient outcomes. We call it The Science of Success®. It means working with clients to ensure the safety and efficacy of every product.
About MedNet: MedNet is an internationally operating sales and marketing organization serving companies in the medical and pharmaceutical industries. Established in 1990, MedNet has a strong partner network, and works with clients to develop solutions which contain products and services from their distinguished partner network.