Apr 13 | Articles
With cardiovascular diseases as the leading cause of death
worldwide, device manufacturers are under immense pressure to produce products
to address these health concerns. However, prior to launching such devices, the
technologies need to be properly tested to ensure success. This article looks
at setting up a system to simulate cardiac flow for testing these medical
devices.
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Mar 8 | News
TÜV SÜD America
Inc. can now provide accredited
certification for ISO 50001 to companies of all sizes and complexities.
Developed by the International Organization for Standardization (ISO) to assist
companies in their efforts to minimize energy consumption, ISO 50001:2011 is
similar...
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Mar 6 | News
The Clinical and Laboratory Standards Institute (CLSI)
recently published Methods for Antimicrobial Susceptibility Testing of
Anaerobic Bacteria; Approved Standard-Eighth Edition (M11-A8). This standard
provides reference methods for the determination of minimal inhibitory...
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Feb 8 | Products
Foster Delivery Science, a business unit for Foster
Corporation, has added comprehensive in-house laboratory services to expedite
the screening of early stage formulations, process development...
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Jan 10 | News
DENVER, CO – Now medical device compliance officers
and quality assurance teams will have reliable access to competitive predicate
device samples required for FDA product clearance, thanks to the newly launched
INBETWEEN Testing Alliance™. A privately held company...
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Oct 24 2011 | News
On December 6, 2011, MET Labs will launch the Program for
Testing Medical Devices for Susceptibility to RFID, to determine potential
adverse events of radio frequency identification (RFID) emissions on electronic
medical devices.
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Aug 10 2011 | Products
Medical device manufacturers seeking increased production
efficiencies and lower costs now possible with use of state-of-the-art leak
detectors for leak-sensitive medical device assembly...
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Jun 27 2011 | Articles
Industry leaders Al Gale, Product and Material Engineer at DDL, John P. McCloy, PE,
CWI President at Accutek Testing Laboratory, Michael Anderson, PhD Technical Manager at Empirical Testing
Corp, Michael BoetzkesQuality Manager, Life Science
Division at Vaisala Canada Inc., and Warren Ward-Stacey Sales Director—Life Sciences at PRISYM ID respond to
questions regarding testing and FDA compliance.
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May 10 2011 | Design Notes
Fluke Biomedical announced today a major expansion of
service options for their customers across the United States. New CarePlans
extended-warranty packages, as well as onsite and mobile services...
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Nov 17 2010 | Articles
Participants: Jeffrey D. Lind, President, Compliance West, USA; Brandon Tillman, Sales Manager, Nelson Laboratories; Dave Kralovetz, Medical Account Development Manager, Cincinnati Test Systems; Lisa Olson, Vice President of Testing and Service Development, WuXi AppTec
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Nov 10 2010 | Articles
One of the critical goals of a medical device manufacturing project
is to eliminate the occurrence of product failure. While there are a
number of methodologies to implement in order to help increase the
chances of success, this article highlights one technique that relies on
multi-variate data analysis to achieve the goal.
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Oct 5 2010 | Products
For over 35
years, the company provides clients with the respect they deserve and offers
testing to meet customers' needs in the areas of microbiology, chemistry,
toxicology/biocompatibility, and stability/accelerated aging.
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Aug 19 2010 | News
The FDA is reopening until September 15, 2010, the comment period for the notice that published in the Federal Register of Thursday, June 17, 2010 (75 FR 34463).
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Aug 18 2010 | Design Notes
Medical device designers and manufacturers seeking to use rapidly
advancing laser die cutting technology for faceplates, membrane switches...
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Aug 18 2010 | Articles
In the race for convenient, single-use diagnostics, an emerging American company is bringing speed, ease of use, and affordability to the detection of bacteria. By applying a simple, yet revolutionary, idea to the old-fashioned Petri dish, BioNanoPore test kits show quantitative results in a matter of hours compared to the potential one to three days with traditional Petri dish methods.
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Aug 18 2010 | Articles
Product testing is a critical component in the development of a medical device. But how many engineers truly understand the importance of what are arguably the three most crucial tests for a medical device? This article reviews these three tests–cytotoxicity, sensitization, and irritation–and offers some insight that will ideally make them go more smoothly for engineers.
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Jul 21 2010 | Articles
Diagnostic
laboratories have an important role to play in ensuring patient safety. The
chance for human errors and omissions is high in specimen collection, testing,
and blood transfusions because these processes have so many manual steps. Automating
specimen collection and transfusion management can create closed loop systems
that virtually eliminate errors in labeling of specimens, incorrect patient
draws, and incorrect transfusions.
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