Inside: Read about a new testing system for human interface adhesives in “Next Generation Human Interface Adhesive Sections,” from Avery Dennison Medical Solutions. Shared are professionals’ opinions on replacing pharma, testing and FDA compliance, and telemonitoring. Additionally, read about ultra short pulse laser processing, green laser marking, electromechanical and mechanical devices, and molding.
MDT and ECN present the 2011 Medical Electronics Resource Guide. Inside: Find a list of products with contact information for numerous companies. Categories include: boards and modules; electromechanical and mechanical devices; integrated circuits; optoelectronics and displays; packaging and interconnects; passive and discrete components; power sources; sensors; test and measurement; and wireless system components.
Inside: Read about selecting the right tubing in “11 Critical Question Areas of Tubing,” from Duke Empirical, Inc. Shared are professionals’ opinions on device design, portable medical, and advanced materials. Additionally, read about value added packaging, sensors, connecting miniaturized devices, ceramic, packaging, miniaturizing magnetic switches, and look at a MD&W West Show preview.
Inside: Read about different outsourcing generations in “4G Outsourcing Partnerships,” from Minnetronix. Shared are professionals’ opinions on the year in review, machining, and patient management devices. Additionally, read about innovative technologies for motors, compressor airs out pump shortcomings, pressure sensors, and medical imaging. Check out the selection of products, as well as the offerings for engineers in Design notes.
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.