Medical Design Briefs: 2021 Technology Leaders - 18

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Eurofins Medical Device Testing
2425 New Holland Pike
Lancaster, PA 17601
Phone: 717-656-2300
Fax: 717-656-3772
E-mail: medical-device@eurofins.com
www.eurofins.com/medical-device
Target Markets
From implants and instruments, to single-use and combination
products, as well as active electronic devices, Eurofins
Medical Device Testing works with medical device companies to
provide the optimal testing strategy for all types of class I, II,
and III medical devices.
Company Description
With extensive knowledge of commercialization processes,
regulatory requirements and scientific trends in the Industry,
Eurofins Medical Device Testing offers regulatory compliance
expertise and experienced GMP/GLP/ISO 17025 testing to
ensure rapid turnaround times with the highest level of service
and advanced technologies for your analytical chemical, microbiological,
biocompatibility, electrical, mechanical and package
testing needs.
Our team has been assisting companies with developmental
testing for over 40 years; and our global network of 720 laboratories
in North America, Europe and Asia Pacific the highest level
of instrument technology with a full scope of testing services.
Eurofins Medical Device Testing can develop and execute your
test plans and navigate the regulatory pathway to market anywhere
in the world. Our laboratories maintain quality systems
compliant with cGMP, GLP, and ISO 17025, and conduct testing in
accordance with ISO, ASTM, ANSI, AAMI standards, and custom
test methodologies to meet the unique needs of our customers.
Products/Services Offered
* Analytical Chemistry -
Our chemistry laboratories
are equipped
with nearly 400 HPLCs
and 100 GCs with more
than 600 detectors.
* Microbiology - We offer
validations for terminal
sterilization, reprocessing
of re usable devices,
and environmental mon -
itoring to support your
clean manufacturing
facilities.
* Biocompatibility Testing
- Our global biocompatibility
team includes
a vast group of certified
veterinarians, path olo -
gists and toxicologists.
* Electrical & Mechanical Testing - We perform testing of active
medical devices for compliance to electrical requirements of
ISO 60601.
* Package Testing - We provide the full range of testing
required to assess every aspect of product packaging, from
sterile seal integrity through pallet-level transit testing, to
label durability and UDI compliance.
* Stability Testing & Storage - Our laboratories contain over
187,000 cubic feet of environmental chamber space for accelerated
and real-time stability and aging studies.
www.eurofins.com/medical-device
18
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Medical Design Briefs 2021 Technology Leaders
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Medical Design Briefs: 2021 Technology Leaders

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