Inside: Read about enhancements in protection methods and power densities in “Charging Forward with Lithium-Ion Battery Technology,” from International Components Corp. Shared are professionals’ opinions on marketing, testing, and ER/surgical devices. Additionally, read about surgical device redesign, power, and five material considerations. Check out the selection of products, as well as the offerings for engineers in Design notes.
Inside: Read about low-volume layered manufacturing in “Parts Without Limits,” from Quickparts. Shared are professionals’ opinions on implantables and medical devices related to the military. Additionally, read about implantable cardiac devices, avoiding molding mishaps, disposables, and packaging and interconnects. Check out the selection of products, as well as the offerings for engineers in Design notes.
How to Respond to (and Avoid) FDA Form 483 Observations for Temperature, Humidity and Other Controlled EnvironmentsAugust 26, 2010 7:57 am | by Ken Appel White Papers
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.
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.
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.
Integrating Quality by Design (Qbd) in Medical Device Manufacturing - Concept, Benefits and ChallengingJuly 28, 2010 4:57 am | by Igor Veljanovski, Stevens Institute of Technology White Papers
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.
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.
Inside: Read about asking the right questions about high performance plastic from micromolding an MIS device in “The Critical Questions When Micromolding for an MIS Device,” from Mikrotech. Shared are professionals’ opinions on FDA review process and wireless medical technology. Additionally, read about lasers for orthopedics, 3D imaging, package testing, sensors, testing, and Petri dish diagnostics.
Inside MDT’s 2010/2011 Buyers’ Guide find a manufacturer and product directory, with a product index. Categories include: component fabrication; design/manufacturing services; electronic components; facility equipment/software; fluid/air transfer; hardware; materials; packaging/sterilization; and testing.
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.
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.
Taking the time to perform several routine maintenance procedures on assembly conveyors significantly adds to the efficiency and longevity of the system.
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.
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.
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.