Different types of screw threads have evolved for fastening, and hydraulic systems. Of special concern are plastic-to-metal, taper/parallel threaded joints in hydraulic circuits. A discussion and recommendations are provided to create an awareness of different types of threads and how they are used.
Calibration, maintenance, and validation activity, despite operating within the same department in some organizations, have generally been managed separately, each with their own procedures and their own computerized management systems. Since even calibration and maintenance professionals tend to access records differently and track different types of information, these separate and unconnected systems made sense. However with new regulatory pressures and in search of greater productivity and efficiency, leaders in the life science industries have explored and experimented with different ways to harmonize these systems. Until recently, the available options have required significant compromises to be made. This paper discusses the evolution of the driving forces and the available solutions for harmonizing calibration, maintenance and validation, concluding with the latest technologies designed to eliminate the need for the departmental compromises previously required to achieve harmonization.
Teleflex Medical OEM, in conjunction with researchers at the University of Connecticut, has developed a tough, high-modulus composite with potential for bone fixation. Fabricated from a unidirectional, fibrous PLLA/apatite, the composite exhibits excellent mechanical properties which correlate to those of natural bone while featuring excellent surface bioactivity. The entire composite is bioabsorbable whereby a device made from the composite will gradually be replaced by natural bone tissue at the implantation site. Early studies indicate integration can occur firmly and permanently with the surrounding tissue. In addition, such prepared composites may have the potential to be used to control the release of growth factors to enhance bone cell stimulation.
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. This white paper will seek to define the various types and define the options to be considered when deciding whether to build or buy a single-axis actuator, also known as a linear guide, slide or table in the parlance of particular industries.
Medical device manufacturers have long marketed their products with limited concern for costs. But today, an aging population and skyrocketing medical costs are prompting private insurers and government payers worldwide to limit reimbursements for medical devices. Medical device manufacturers are responding in two ways, by: * Justifying product price points by carefully documenting their value in improving patient outcomes. * Reducing costs throughout their operations by rethinking how they sell and market their products, outsourcing operations, and implementing lean manufacturing principles. Download this white paper by clicking on the link below and learn how enterprise software enables medical device manufacturers to more successfully implement these price justifications and cost cutting initiatives.
Aftermarket or refurbished battery packs are available for most portable devices. This white paper presents the results of several product teardowns on aftermarket battery packs, both commercial and medical, and explains how substandard aftermarket packs can cut corners on cost, safety mechanisms, and battery performance. These teardowns expose electronic & mechanical design issues, as well as poor manufacturing practices and regulatory violations.
In this paper, you will learn what international challenges manufacturers face and how they can best respond to them without affecting production and delivery. The best labeling practices for international markets includes plans for adapting to diverse and evolving regulatory requirements; meeting localization standards; optimizing translation processes; and managing label real estate challenges.
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
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
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.