The CE Marking process tends to be complicated and time consuming. This white paper offers straight forward and easy to understand steps to successful CE marking. From this guide you will learn; why CE marking is easier than you think, an 11...
Medical device manufacturers that assemble devices and equipment must meet stringent FDA...
A 3D printer is a machine that creates objects from plastic or other materials using an additive...
In many industries, manufacturers have reduced development times by using COTS (commercial-off-...
This paper will address the particular design and fabrication challenges of medical cables. It will examine the design parameters, material choices and manufacturing requirements that medical device manufacturers need to know to ensure that medical device interconnect is precise, reliable and durable – and protect them from liability.
This paper addresses the capabilities, roles and positioning of systems geared for professional use. Beginning with the most basic information – the definition of 3D printers – this whitepaper positions the two product classes.
A 3D printer is a machine that creates objects from plastic or other materials using an additive manufacturing process. Additive manufacturing produces objects in a succession of layers from the bottom, up. This is the opposite of traditional subtractive manufacturing processes.
To process the imaging and video feeds during surgical operations, long lifecycle computers are utilized. To handle the demands of real-time image and signal processing, these computers rely on high-performance Intel Core and Xeon processors, along with powerful graphics cards. Portwell provides a critical building block for such a system.
Three trends are driving a dramatic increase in the number and diversity of remote-care medical devices entering the market: aging populations in industrialized countries, pressures to reduce health care costs, and a new focus on primary and secondary care.
Many medical devices must bring together a disparate array of hardware and software components, as well as support a sophisticated, multi-layered Human-Machine Interface (HMI).
Download this whitepaper on choosing an embedded OS for medical devices where reliability, recovery and safety are critical differentiators. It provides a high-level list of requirements that device manufacturers can use to evaluate OSs considerations.
This paper explains what IEC 62304 compliance means for manufacturers. It also describes the larger context of systems and software engineering best practices at work in many of today’s most successful companies.
Diagnostic Grifols, a leading medical device provider, is implementing a solution to enhance collaboration throughout its product development cycle, sees significant results in time to market and regulation compliance.
The challenges faced by medical device manufacturers can no longer be solved by examining problems individually. IBM Rational solution for medical devices provides a comprehensive and holistic answer that makes it easier to comply with regulatory mandates, while at the same time improving the efficiency and effectiveness of the product development team.
Significant changes are happening to European environmental regulations. While there has been a great deal of discussion and debate over the past few years, in June 2011 the European Union issued Directive 2011 65 EU on the restriction of the
There are substantial changes in the 3rd Edition of IEC 60601-1, and understanding all aspects of these changes is the key to turning this new standard into a benefit for you as a medical device manufacturer. This paper is designed to explain the philosophy behind the the major changes in the standard, explain how these changes will affect device manufacturers, and share information as to which resources are available to help make the smoothest possible transition to the new Standard.
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 (GE, Google, HP, IBM, Intel, Microsoft, Philips, Qualcomm, Siemens, TI, Walmart, etc,) entering the space, along with prominent media coverage and a rise in the number of conferences highlighting the technology. A recent national study by Philips showed compelling and tangible benefits with telehealth. medicare now reimburses for telehealth under particular circumstances and some private payers in certain geographies are also paying providers to use telehealth. This whitepaper provides a review of the state-of-the-art in tele-machine and wireless medical devices including the key drivers, important developments in end-to-end health and wellness solutions, the opportunity ahead of us, and key challenges for wireless medical device deployments.
The medical devices industry, as well as the pharmaceutical industry, is slowly but indisputably accepting the concept of Quality by Design into its design and development product phases, and is introducing the statistical tools and methods of the concept into its process verification and validation phases as well. The Quality by Design concept or approach has found its implementation in the medical devices life cycle management, under the guidance of risk regulations by the International Conference on Harmonization. Since the importance of successful implementation of this concept is ever more evident in industry, this white paper will therefore discuss the concept and its possible implementation in the medical devices industry, along with the benefits and concerns expressed by the manufacturers.
It is widely known and published that modern sterilization techniques used in the healthcare industry can have a detrimental effect on thermoplastic polymers. In particular, gamma sterilization, which is the most common ionization method, can cause substantial changes to occur in polymeric materials. Polymer chain scission and cross linking can both occur, altering the physical properties and appearance of materials and ultimately affecting the functionality of a device utilizing these materials. RTP Company’s TPE (Thermoplastic Elastomer) Division has initiated a series of projects to measure the effect different sterilization methods have on RTP Company’s standard TPE products used in medical devices. This paper discusses the effect gamma sterilization has on these various TPE compounds produced by RTP Company for the healthcare industry.