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.
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.
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.
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.
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.
Applications in the healthcare industry, medical devices in particular, have some demanding requirements for thermoplastic materials that are unique to this arena.
Three cell chemistries currently dominate the growing portable application market: Nickel-Metal Hydride (NiMH), Lithium Ion (Li-Ion), and Lithium Polymer (Li-polymer).