Aug 26
No cGMP manufacturer wants to receive a Form 483 letter (“Notice
of Inspectional Observations”). In such stringently controlled industries as pharmaceutical/biotechnical/medical
device development, manufacturing and warehousing, receiving a list of
deficiencies can feel like a heavy blow to your quality system.
|
Aug 26
Evolving end-user expectations for differentiated software
functionality, sustained time-to-market, and cost pressures continue to fuel
new software development within embedded devices. Time-to-market and cost
considerations will continue to drive embedded systems manufacturers to utilize
international engineering resources and legacy code assets whenever efficient
and economical.
|
Aug 25
One of the most challenging assignments for a scientist or engineer in a cutting edge technical field is working effectively with a patent attorney. The world of the scientist or engineer is quantitative and precise.
|
Jul 28
The medical devices industry, as well as the pharmaceutical industry, is slowly butindisputably accepting the concept of Quality by Design into its design and developmentproduct phases, and is introducing the statistical tools and methods of the concept intoits process verification and validation phases as well. The Quality by Design concept orapproach has found its implementation in the medical devices life cycle management,under the guidance of risk regulations by the International Conference onHarmonization. Since the importance of successful implementation of this concept isever more evident in industry, this white paper will therefore discuss the concept and itspossible implementation in the medical devices industry, along with the benefits andconcerns expressed by the manufacturers.
|
Jul 13
In the life sciences industry, Customer Service and
Operations directors face the challenge of maintaining high margins to
absorb
soaring drug development costs while keeping customers happy and away
from the
competition.
|
May 14
This whitepaper describes the requirements for FDA 21 CFR Part 11 compliance at a high level and discusses how Epicor enables FDA regulated manufacturers to fulfill these demands.
|
May 7
Wireless technologies are bringing about dramatic improvements in the quality of healthcare by allowing patients unprecedented mobility while providing healthcare professionals with easy and real-time access to patient data. Awareness of telehealth and wireless medical applications is increasing with more high profile companies entering the space, along with prominent media coverage and a rise in the number of conferences highlighting the technology.
|
May 7
Taking the time to perform several routine maintenance procedures on assembly conveyors significantly adds to the efficiency and longevity of the system.
|
May 7
In a technology enabled future, a bathroom mirror with a retinal scanner
behind the glass collects vital signs and looks for clues to
retinopathy, and a toilet with an embedded processor analyzes urine to
identify kidney infections or the progression of chronic conditions such
as diabetes.
|
May 7
It is well known and published that modern sterilization techniques can
have a detrimental effect on polymers. In particular, gamma
sterilization, which is the most common ionization method, can cause
substantial changes in polymeric materials.
|
May 7
Laser cutting, a.k.a. digital die cutting, uses high-powered lasers to
vaporize materials in the lasers’ beam path. The powering on and off of
the laser beam and the way in which the beam path is directed towards
the substrate effects the specific cuts that the artwork requires.
|
May 7
Medical device companies can reduce development costs and accelerate
time to market by automating cross-departmental information sharing
systems. This white paper discusses business content and process
applications and product content and process applications, and explains
how companies are utilizing these systems.
|
May 7
A variety of linear motion devices are available today for performing
the function of single-axis movement, whether it be for an assembly
operation, testing, packaging or simple motion control.
|
May 7
Applications in the healthcare industry, medical devices in particular,
have some demanding requirements for thermoplastic materials that are
unique to this arena.
|
May 7
Three cell chemistries currently dominate the growing portable
application market: Nickel-Metal Hydride (NiMH), Lithium Ion (Li-Ion),
and Lithium Polymer (Li-polymer).
|
May 7
Over the past 15 years, there have been many advances in medical imaging
technology, from ultrasound, to Digital X-Ray and magnetic-resonance
imaging (MRI). New applications are also being developed, including
hyperspectral imaging and 3D/4D scans which can produce clinically
relevant images.
|
May 7
With new regulatory pressures and in search of greater productivity and efficiency, leaders in the life science industries have explored harmonizing calibration, maintenance and validation management systems. Until recently, the available options required significant compromises to productivity.
|