Medical Design Briefs - February 2024 - 25

Sponsored Content
Eurofins Medical Device Testing
2425 New Holland Pike
Lancaster, PA 17601
Phone: 717-656-2300
Fax: 717-656-3772
E-mail: medical-device@bpt.eurofinsus.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.
About Our Company
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 >20 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.
* Analytical Chemistry -
Our chemistry labora-
tories 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 ologists
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.
MD&M West Booth 2077
Products/Services Offered
Medical Design Briefs, February 2024
www.medicaldesignbriefs.com
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Medical Design Briefs - February 2024

Table of Contents for the Digital Edition of Medical Design Briefs - February 2024

Medical Design Briefs - February 2024 - Cover Flap
Medical Design Briefs - February 2024 - Cover Flap1A
Medical Design Briefs - February 2024 - Cover1
Medical Design Briefs - February 2024 - Cover2
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Medical Design Briefs - February 2024 - Cover3
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